[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boehringer Ingelheim\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":544},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,41,63,85,105,125,145,165,186,206,225,246,268,289,310,332,353,374,395,417,437,456,477,499,523],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651033","a-study-to-test-whether-survodutide-helps-people-with-type-2-diabetes-control-their-blood-sugar-100651033",false,"NCT07754461","A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar","A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin","Inclusion criteria:\n\n1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)\u002FEuropean association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:\n\n   1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol\u002Fmol) and \\\u003C9.5% (\\\u003C80 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and\u002For Maximum tolerated dose of sulfonylurea and\u002For Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   3. Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)\u002Fday with or without stable dose of metformin and\u002For SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1)\n3. Body mass index (BMI) ≥23 kg\u002Fm2 at screening (Visit 1)\n4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial\n5. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)\n\nExclusion criteria:\n\n1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)\n2. Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist\u002Fglucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion\u002Fnaltrexone, orlistat, phentermine, and phentermine\u002Ftopiramate\n3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)\n4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)\n5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study\n6. Body weight change (self-reported) \\>5% within 90 days before screening (Visit 1)\n7. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and\u002For abdominoplasty, if performed \\>1 year before screening (Visit 1), (2) lap banding, if the band has been removed \\>1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed \\>1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\>1 year before screening (Visit 1).\n8. Answered \"yes\" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the \"Suicidal Behaviour\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)\n9. Further exclusion criteria apply.","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg\u002Fm2 or higher can join.\n\nThe study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.\n\nDepending on a person's diabetes treatment, a person will be assigned either to\n\n* Part A: healthy eating and physical activity\n* Part B: diabetes tablets (no injection of insulin)\n* Part C: injection of insulin (with or without diabetes tablets)\n\nParticipants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.\n\nParticipants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.",[27],"Type 2 Diabetes","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":21},"2026-08-24",{"date":36,"type":21},"2028-05-01",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",120,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100635495","phase-1-a-study-in-people-with-diabetic-macular-edema-to-test-how-well-different-doses-of-bi-3812465-are-tolerated-100635495","NCT07553429","A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated","A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I\u002FIIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema","Inclusion Criteria:\n\nAll participants, study eye:\n\n* Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC).\n* Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging.\n\nAll participants:\n\n* Diagnosis of diabetes mellitus (DM) type 1 or type 2 under regular treatment, with glycated hemoglobin HbA1c \\\u003C12%.\n* Be willing and able to understand the study procedures and the risks involved.\n* Signed and dated written informed consent in accordance with international council for harmonization - good clinical practices (ICH-GCP) and local legislation prior to admission to the trial and any trial related procedures.\n* Age ≥18 years (or above legal age according to local legislation) at time of signing the informed consent form (ICF).\n* Male or female participants\n\n  * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control\n  * For men, contraception (condom or complete abstinence) should be used as precaution to prevent pregnancy of a partner and\u002For exposure of an existing embryo or fetus.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\nAll participants, study eye:\n\n* Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investigator's medical judgment in consultation with the participant, to support the participant's daily functioning.\n* Evidence of active proliferative diabetic retinopathy (PDR).\n* Evidence of active retinal neovascularization (NV) clinical exam and\u002For Ultra-Widefield Color Fundus Photography ((UWF-)CFP) within the early treatment diabetic retinopathy study (ETDRS) 7-field, confirmed by the CRC grading. Potential participants with NV outside of the ETDRS 7-field on ultra-widefield imaging may be included in the trial if this condition, based on the assessment of the investigator, does not require acute treatment.\n* Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle.\n* Additional eye disease in the study eye that could compromise trial participation:\n\n  * Uncontrolled glaucoma or intraocular pressure (IOP) \\>24 mmHg despite treatment\n  * History of high myopia \\>8 diopters in the study eye\n  * Anterior segment and vitreous abnormalities in the study eye that would preclude adequate detection of intraocular inflammation (IOI) or other pathologies\n  * Ocular conditions which, at discretion of the investigator, might interfere with the outcome of the trial.\n* Previously received ocular gene therapy or cell therapy.\n* Corticosteroid use locally or systemically within 1 month prior to Screening.\n* Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy may be permitted, if performed more than 2 months prior to Day 1.\n\nFurther exclusion criteria apply.",{"count":49,"type":21},49,[51,52],"PHASE1","PHASE2","This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans.\n\nThis study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections.\n\nParticipants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.",[55],"Diabetic Macular Edema",{"date":31,"type":32},{"date":58,"type":32},"2026-05-14",{"date":60,"type":21},"2027-07-06",{"name":38,"class":39},30,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100616511","phase-1-a-study-to-test-how-well-different-doses-of-bi-3820768-are-tolerated-by-people-with-advanced-cancer-solid-tumours-100616511","NCT07306559","A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)","A Phase I Study to Determine the Safety and Tolerability of BI 3820768 in Patients With Advanced Relapsed or Refractory Germ Cell Tumours, Endometrial Cancer, or Ovarian Cancer","Inclusion criteria :\n\n1. Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the informed consent forms (ICFs).\n2. For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.\n3. Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n4. Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.\n5. Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.\n6. Patients with advanced, relapsed\u002Frefractory (r\u002Fr) GCT, EC, or OVC.\n7. Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.\n8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nFurther inclusion criteria apply.\n\nExclusion criteria:\n\n1. Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and\u002For Sponsor's assessment).\n2. Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:\n\n   1. Effectively treated non-melanoma skin cancers\n   2. Effectively treated carcinoma in situ of the cervix\n   3. Effectively treated ductal carcinoma in situ\n   4. Other effectively treated malignancy that is considered cured by local treatment\n3. Patient with known leptomeningeal disease or spinal cord compression due to disease.\n4. Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 h prior to the first dose of trial medication are not eligible.\n5. Patients with Hepatitis-C-Virus (HCV) infection, defined as:\n\n   1. Currently receiving curative antiviral treatment for HCV infection, and\u002For\n   2. HCV viral load is above the limit of quantification (HCV RNA positive).\n6. Patients with active hepatitis B virus (HBV) infection (chronic or acute); defined as having a positive hepatitis B surface antigen (HBsAg), and HBsAg test at screening.\n7. Patient with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBcAb) and absence of HbsAg) are eligible. HBV DNA must be obtained in these patients prior study start.\n\nFurther exclusion criteria apply.",{"count":71,"type":21},187,[51],"This study is open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not successful. People can join the study if they have no remaining treatment options or if standard therapy is not suitable. The purpose of this study is to test increasing doses of BI 3820768 to find a dose that people with these types of cancer can tolerate and that may make tumours shrink. BI 3820768 is a type of treatment that may help the immune system fight cancer. This is the first time BI 3820768 is being tested in humans.\n\nThe study has 2 parts based on the way BI 3820768 is given. Depending on when participants join the study, they will receive BI 3820768 through one of two ways to inject the study medicine. All participants receive the study medicine. The medicine is given as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3 weeks.\n\nParticipants are in the study for up to 3 years if they are benefiting from the treatment. During this time, they visit the study site regularly, and some visits will require overnight stays. Doctors will regularly check the size of the tumour and whether it has spread. Researchers want to find the highest dose of BI 3820768 that participants can tolerate by looking at the number of participants with certain severe health problems. The doctors also regularly check participants' health, take blood samples, and note any unwanted effects.",[75,76,77],"Advanced Relapsed or Refractory Germ Cell Tumours","Advanced Relapsed or Refractory Endometrial Cancer","Advanced Relapsed or Refractory Ovarian Cancer",{"date":31,"type":32},{"date":80,"type":32},"2026-02-27",{"date":82,"type":21},"2030-01-28",{"name":38,"class":39},13,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100607987","phase-3-beamion-lung-3-adjuvant-zongertinib-vs-standard-treatment-in-people-with-completely-resected-stage-ii-iiib-nsclc-harboring-activating-her2-tkd-mutations-100607987","NCT07195695","Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations","Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n2. Patients must be ≥18 years old or over the legal age of consent in their country\n3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n   * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n   * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology\u002Fpositive neuroendocrine markers (synaptophysin\u002FCD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n   * Active or known pre-existing or history of non-infectious interstitial lung disease\u002Fpneumonitis\n   * Active infectious disease requiring systemic therapy\n   * Uncontrolled gastrointestinal disorders affecting drug intake\u002Fabsorption\n   * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n   * Significant and\u002For uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \\>470 msec, or ejection fraction \\\u003C50% Further exclusion criteria apply.",{"count":93,"type":21},400,[24],"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.\n\nParticipants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.",[97],"Non-small Cell Lung Cancer",{"date":31,"type":32},{"date":100,"type":32},"2026-01-16",{"date":102,"type":21},"2036-09-02",{"name":38,"class":39},202,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100590086","phase-2-a-study-to-test-whether-bi-1815368-helps-people-with-an-eye-condition-called-diabetic-macular-edema-100590086","NCT06962839","A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema","A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)","Inclusion criteria:\n\n* ≥18 years of age\n* Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \\\u003C12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline\n* Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening\n* Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20\u002F320 to 20\u002F32) at screening Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Macular edema considered to be due to other causes than CI-DME in the study eye\n* Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye\n* Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and\u002For more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye\n* Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)\n* Active ocular inflammation of any history of intraocular inflammation within 1 year\n* Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1 Further exclusion criteria apply.",{"count":113,"type":21},300,[52],"This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose.\n\nThis study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months.\n\nParticipants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.",[117],"Macular Edema",{"date":31,"type":32},{"date":120,"type":32},"2025-06-05",{"date":122,"type":21},"2027-09-29",{"name":38,"class":39},90,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100587975","phase-3-a-study-to-test-whether-vicadrostat-bi-690517-in-combination-with-empagliflozin-helps-people-with-heart-failure-and-a-weak-pumping-function-of-the-left-side-of-the-heart-100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":133,"type":21},4200,[24],"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[137],"Heart Failure",{"date":31,"type":32},{"date":140,"type":32},"2025-05-20",{"date":142,"type":21},"2029-02-22",{"name":38,"class":39},589,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690","NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply",{"count":153,"type":21},1590,[24],"This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[157],"Metabolic Dysfunction Associated Steatohepatitis",{"date":31,"type":32},{"date":160,"type":32},"2024-11-12",{"date":162,"type":21},"2029-06-05",{"name":38,"class":39},445,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":173,"type":21},1800,[24],"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[177,178],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":31,"type":32},{"date":181,"type":32},"2024-10-14",{"date":183,"type":21},"2031-12-27",{"name":38,"class":39},528,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100556954","easi-kidney-the-studies-of-heart--kidney-protection-with-bi-690517-in-combination-with-empagliflozin-100556954","NCT06531824","EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)","A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease","Key Inclusion Criteria:\n\n* Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires:\n\n  1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \\\u003C45 mL\u002Fmin\u002F1.73m² (irrespective of diabetes status); or\n  2. No self-reported diabetes: CKD-EPI eGFR ≥45 \\\u003C90 mL\u002Fmin\u002F1.73m² with urine albumin-to-creatinine ratio (uACR) ≥150 mg\u002Fg (or protein-to-creatinine ratio ≥225 mg\u002Fg); or\n  3. Self-reported diabetes: CKD-EPI eGFR ≥45 \\\u003C90 mL\u002Fmin\u002F1.73m² with uACR ≥30 mg\u002Fg (or protein-to-creatinine ratio ≥45 mg\u002Fg).\n* Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.\n\nKey Exclusion Criteria:\n\n* Blood potassium of \\>5.2 mmol\u002FL at screening visit\n* Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \\>3x Upper Limit of Normal (ULN) at Screening visit (only one is required, with ALT preferred)\n* Known liver cirrhosis\n* On dialysis, functioning kidney transplant, or scheduled living donor transplant\n* Treated with new immunosuppression therapy for new (or relapse\u002Fflare of pre-existing) kidney disease within the last 60 days\n* Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)\n* Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)\n* Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":194,"type":21},11000,[24],"This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation.\n\nAfter a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study.\n\nThe doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 5 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.",[198],"Kidney Disease, Chronic",{"date":31,"type":32},{"date":201,"type":32},"2024-08-30",{"date":203,"type":21},"2028-08-30",{"name":38,"class":39},515,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100548691","phase-3-a-study-to-test-whether-vicadrostat-in-combination-with-empagliflozin-helps-people-with-heart-failure-100548691","NCT06424288","A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","Inclusion criteria:\n\n1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\\u003C27 kg\u002Fm²: ≥300 pg\u002FmL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg\u002Fm² to \\\u003C35 kg\u002Fm²: ≥220 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg\u002Fm²: ≥125 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg\u002FmL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg\u002FmL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg\u002Fg, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local\u002Finternational guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery\u002FCABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.",{"count":214,"type":21},6000,[24],"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat\u002Fempagliflozin group: participants take vicadrostat\u002Fempagliflozin as tablets once a day.\n* Placebo\u002Fempagliflozin group: participants take placebo\u002Fempagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.",[137],{"date":31,"type":32},{"date":220,"type":32},"2024-06-17",{"date":222,"type":21},"2028-05-22",{"name":38,"class":39},652,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100513315","phase-1-a-study-to-test-how-bi-764532-is-taken-up-by-tumours-in-people-with-small-cell-lung-cancer-or-neuroendocrine-cancer-100513315","NCT05963867","A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer","An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Weight ≥ 60kg\n* Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n* Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1\n* Subjects with brain metastases are eligible provided they meet the following criteria:\n\n  * radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532,\n  * patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:\n\n  * effectively treated non-melanoma skin cancers\n  * effectively treated carcinoma in situ of the cervix\n  * effectively treated ductal carcinoma in situ\n  * other effectively treated malignancy that is considered cured by local treatment\n* Major injuries and\u002For surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures\n* Known leptomeningeal disease or spinal cord compression due to metastatic disease\n* Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed\n* Active infection that requires medical therapy or other clinically significant intervention\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks prior to study entry (confirmed via polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection\n* Any of the following known laboratory evidence of hepatitis virus infection:\n\n  * Positive results of hepatitis B surface (HBs) antigen\n  * Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA (HBV-DNA)\n  * Presence of hepatitis C ribonucleic acid (RNA)\n* Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.",{"count":233,"type":21},12,[51],"This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.\n\nParticipants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.",[237,238],"Small Cell Lung Carcinoma (SCLC)","Neuroendocrine Neoplasms",{"date":31,"type":32},{"date":241,"type":32},"2024-08-06",{"date":243,"type":21},"2026-12-25",{"name":38,"class":39},1,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100644100","phase-2-a-study-to-test-whether-bi-3034701-helps-people-to-lose-weight-who-live-with-obesity-or-overweight-100644100","NCT07662122","A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight","A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight","Inclusion criteria:\n\n1. Male or female, age ≥18 to \\\u003C75 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥30 kg\u002Fm² at screening, OR BMI ≥27 kg\u002Fm² at screening with the presence of at least 1 weight-related complication.\n3. History of at least one self-reported unsuccessful dietary effort to lose body weight\n4. Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently\n5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information sheet and in protocol.\n6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Sign the informed consent form (ICF); Learn how to self-inject the investigational medicinal product (IMP)(s) in the abdomen as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP(s)) OR Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and physical activity plan), maintain diaries, complete required questionnaires, and handle the IMP(s) as described in the instructions for use (IFU)\n\nExclusion criteria:\n\n1. Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening\n2. Treatment with anti-obesity medication and\u002For body weight change-inducing medication within 3 months before screening\n3. Prior surgery of the gastrointestinal (GI) tract that could interfere with body weight including minimally invasive\u002Fendoscopic bariatric devices and any bariatric or metabolic surgery involving resection, sleeve gastrectomy, or bypass procedures (e.g. Roux-en-Y, one-anastomosis gastric bypass, duodenal-jejunal bypass sleeve), regardless of whether the device or bypass was removed. The following are allowed: (1) liposuction and\u002For abdominoplasty, if performed \\>1 year before screening, (2) lap banding, if the band has been removed \\>1 year before screening, (3) intragastric balloon, if the balloon has been removed \\>1 year before screening\n4. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)\n5. A Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol\u002Fmol) as measured by the central laboratory at screening\n6. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose-lowering agent starting within 3 months before screening\n7. Use of glucagon-like-peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR) or neuropeptide Y receptor 2 (NPY2R) agonists (or the combinations thereof) within 3 months before screening\n8. Answered \"yes\" to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the \"Suicidal Behaviour\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening visit up to and including the randomisation visit Further exclusion criteria apply.","74 Years",{"count":113,"type":21},[52],"This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg\u002Fm2 or more, or a BMI of 27 kg\u002Fm2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study.\n\nThe purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.",[258,259],"Obesity","Overweight","2026-08-19",{"date":29,"type":32},{"date":263,"type":32},"2026-06-30",{"date":265,"type":21},"2027-08-18",{"name":38,"class":39},55,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100634538","phase-3-fibroneer-act-a-study-to-test-whether-nerandomilast-helps-people-with-fibrosing-interstitial-lung-disease-at-risk-for-disease-progression-100634538","NCT07540988","FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression","A Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)","Inclusion criteria :\n\n1. Male and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial\n3. Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator\n4. Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis\u002F bronchiolectasis and\u002For honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomization\n5. Time since ILD diagnosis ≤3 years before randomization\n6. FVC ≥45% of predicted normal at Visit 1\n7. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1\n8. Patients treated with permitted immunosuppressive\u002Fimmunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening period\n9. Further inclusion criteria apply.\n\nExclusion criteria :\n\n1. Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) 2022 guidelines\n2. Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)\n3. Known diagnosis of sarcoidosis\n4. Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review\n5. Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection\u002FCoronavirus Disease 2019 (COVID-19) (based on investigators judgement)\n6. Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator\n7. Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator\n8. Prior or current use of nerandomilast, nintedanib, or pirfenidone\n9. Further exclusion criteria apply.",{"count":276,"type":21},466,[24],"This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression.\n\nParticipants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[280],"Interstitial Lung Diseases","NOT_YET_RECRUITING",{"date":29,"type":32},{"date":284,"type":21},"2026-08-28",{"date":286,"type":21},"2028-12-12",{"name":38,"class":39},162,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162","NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.",{"count":298,"type":21},448,[24],"Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[302],"Systemic Sclerosis",{"date":29,"type":32},{"date":305,"type":32},"2026-07-27",{"date":307,"type":21},"2030-03-17",{"name":38,"class":39},246,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100624403","phase-2-a-study-to-test-whether-different-doses-of-bi-3000202-help-people-with-systemic-lupus-erythematosus-sle-100624403","NCT07409181","A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)","Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \\\u003C75 years\n2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 24 weeks prior to screening\n3. At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody\n\n   \\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points\n4. At least 1 British Isles Lupus Assessment Group (BILAG) A and\u002For 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator\n5. On SLE background therapy with a maximum of 1 immunosuppressant and\u002For 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and\u002For oral corticosteroids at a dose of ≤30 mg\u002Fday prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Drug-induced SLE\n2. Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments\n3. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis\u002Fmononeuropathy multiplex, chorea, and polyneuropathy\n4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \\>2 × Upper Limit of Normal (ULN) and\u002For Urine Protein Creatinine Ratio (UPCR) that is unstable or \\> 3mg\u002Fmg (339 mg\u002Fmmol)\n5. Oral corticosteroids (prednisone or equivalent) \\>30 mg\u002Fday at screening Further exclusion criteria apply.",{"count":318,"type":21},405,[52],"This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.\n\nParticipants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.\n\nParticipants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.",[322],"Systemic Lupus Erythematosus",[324],"Lupus",{"date":29,"type":32},{"date":327,"type":32},"2026-04-20",{"date":329,"type":21},"2029-07-08",{"name":38,"class":39},140,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100620721","phase-3-a-study-to-test-if-tenecteplase-helps-people-to-recover-from-an-acute-stroke-when-given-more-than-45-hours-after-the-person-was-last-seen-well-100620721","NCT07361302","A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well","TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue","TENACITY","Inclusion criteria:\n\n1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \\>4.5 h before time of presumed randomisation\n4. Pre-stroke modified Rankin scale (mRS) ≤1\n5. Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)\n\nExclusion criteria:\n\n1. Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation\n2. Occlusion of the internal carotid artery (ICA)\n3. High-risk patients (increased risk of thrombolysis related hemorrhage)\n4. Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans\n5. Contra-indication to contrast brain imaging with CT and MRI\n6. Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \\> 25)\n7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator\n8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h\n9. Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.",{"count":341,"type":21},1325,[24],"This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot.\n\nThe purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke.\n\nParticipants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment.\n\nParticipants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.",[345],"Acute Ischemic Stroke",{"date":29,"type":32},{"date":348,"type":32},"2026-02-17",{"date":350,"type":21},"2027-10-02",{"name":38,"class":39},250,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":360,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100609861","phase-3-a-study-to-find-out-if-bi-764198-helps-adults-and-adolescents-with-a-kidney-condition-called-focal-segmental-glomerulosclerosis-fsgs-100609861","NCT07220083","A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)","A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants","Inclusion criteria:\n\n1. Male or female participants ≥12 years old on the day of signing informed consent\u002Fassent (Visit 1)\n2. Weight of ≥40 kg at the screening visit (Visit 1)\n3. Body mass index (BMI) of ≤40 kg\u002Fm² at the screening visit (Visit 1)\n4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:\n\n   * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR\n   * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)\n5. Urine protein-creatinine ratio (UPCR) ≥1500 mg\u002Fg based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)\n6. Estimated glomerular filtration rate (eGFR)\n\n   * For adult participants (≥18 years): ≥25 mL\u002Fmin\u002F1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)\n   * For adolescent participants (12 to \\\u003C18 years): ≥25 mL\u002Fmin\u002F1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)\n2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)\n3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)\n4. A history of organ transplantation or planned organ transplantation during the course of the trial\n5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.","12 Years",{"count":362,"type":21},286,[24],"PODOMOUNT-pFSGS\n\nThis study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.\n\nParticipants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine.\n\nParticipants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS.\n\nParticipants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[366],"Focal Segmental Glomerulosclerosis",{"date":29,"type":32},{"date":369,"type":32},"2026-02-16",{"date":371,"type":21},"2029-01-24",{"name":38,"class":39},306,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":394},"100601242","phase-3-a-study-to-find-out-how-empagliflozin-is-tolerated-and-if-it-helps-children-and-adolescents-with-chronic-kidney-disease-empa-kidney-kids-100601242","NCT07107945","A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)","A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)","Inclusion Criteria:\n\n* Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity).\n* Age 2 to 17 years at screening Visit 1.\n* Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to \\\u003C90 mL\u002Fmin\u002F1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg\u002Fg\n* Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial.\n* Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Confirmed type 1 or type 2 diabetes mellitus.\n* History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation.\n* Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.\n* Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion).\n* Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children \\\u003C4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1.\n* Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.\n* Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1.\n* Severe, uncontrolled hypertension (based on investigator's judgement).\n* Further exclusion criteria apply.","2 Years","17 Years",{"count":40,"type":21},[24],"This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.\n\nParticipants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.",[387],"Chronic Kidney Disease",{"date":29,"type":32},{"date":390,"type":32},"2025-12-09",{"date":392,"type":21},"2028-04-14",{"name":38,"class":39},97,{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":403,"type":21},11800,[24],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[407,408,409],"Diabetes Mellitus, Type 2","Hypertension","Cardiovascular Diseases",{"date":29,"type":32},{"date":412,"type":32},"2025-07-22",{"date":414,"type":21},"2029-12-21",{"name":38,"class":39},1147,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":360,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100583174","phase-3-the-airtivity-study-a-study-to-find-out-whether-bi-1291583-helps-people-with-bronchiectasis-100583174","NCT06872892","The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis","A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)","Inclusion criteria:\n\n* Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.\n* Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.\n* Age of participants when signing the informed consent\u002Fassent ≥12 years.\n\n  \\-- Adolescents need to weigh at least 35 kg at Visit 1.\n* Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.\n\nParticipants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.\n\n* Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.\n* History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:\n\n  * at least 2 exacerbations, or\n  * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \\>40 at screening Visit 1 (adults only)\n  * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.\n\nExclusion criteria:\n\n* Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.\n* Allergic bronchopulmonary aspergillosis being treated or requiring treatment.\n* Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment\n* Any findings in the medical examination and\u002For laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.\n* Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.\n* Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.\n* Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.\n* Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).\n* estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \\\u003C30 mL\u002Fmin at Visit 1.\n* Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.",{"count":425,"type":21},1755,[24],"This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).\n\nThe purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.\n\nParticipants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.",[429],"Bronchiectasis",{"date":29,"type":32},{"date":432,"type":32},"2025-06-09",{"date":434,"type":21},"2027-12-20",{"name":38,"class":39},471,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100578076","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-lungfibrosis-related-to-rheumatic-diseases-100578076","NCT06806592","A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases","A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)","Inclusion Criteria:\n\n* Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as\n\n  * Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)\n  * Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent \\>10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review\n* No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:\n\n  * No improvement in absolute forced vital capacity (FVC) % predicted \\>5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted \\>5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)\n  * No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging\u002FHRCT, or other assessments as considered relevant and documented by the Investigator)\n* FVC ≥45% of predicted normal at Visit 1\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1\n* Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:\n\n  * If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2\n  * If using rituximab, participants must have completed their first cycle \\>6 months prior to Visit 2\n* If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2\n* In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned\n* Further inclusion criteria apply\n\nExclusion Criteria:\n\n* Organising pneumonia as predominant pattern in the HRCT\n* Prebronchodilator forced expiratory volume in 1 second (FEV1)\u002F forced vital capacity (FVC) \\\u003C0.7 at Visit 1\n* Acute ILD exacerbation within 3 months prior to Visit 1 and\u002For during the screening period, based on Investigator judgement\n* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period\n* Any suicidal behaviour in the past 2 years\n* Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and\u002For at Visit 2\n* Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1\n* Further exclusion criteria apply",{"count":93,"type":21},[24],"Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease.\n\nParticipants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[280,448],"Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases",{"date":29,"type":32},{"date":451,"type":32},"2025-09-13",{"date":453,"type":21},"2027-07-30",{"name":38,"class":39},154,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},"100565013","phase-2-a-study-to-test-whether-bi-3032950-helps-people-with-ulcerative-colitis-100565013","NCT06636656","A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis","Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis","Inclusion criteria\n\n* Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,\n* Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,\n* Inadequate response, loss of response, or intolerance to treatment with biologic\u002Ftargeted therapy or termination of treatment with biologic\u002Ftargeted therapy for any other reason,\n* Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,\n* Further inclusion criteria apply.\n\nExclusion criteria\n\n* Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),\n* Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),\n* Evidence of colonic moderate\u002Fsevere mucosal dysplasia or colonic adenomas, unless properly removed,\n* Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,\n* Evidence of fulminant colitis or toxic megacolon at screening,\n* Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,\n* Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),\n* Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,\n* Further exclusion criteria apply.","80 Years",{"count":465,"type":21},80,[52],"Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis.\n\nThis study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.\n\nParticipants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.\n\nThe doctors also regularly check participants' health and take note of any unwanted effects.",[469],"Ulcerative Colitis",{"date":31,"type":32},{"date":472,"type":32},"2024-12-11",{"date":474,"type":21},"2029-07-30",{"name":38,"class":39},41,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":486,"type":21},1700,[24],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[490,491],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis",{"date":29,"type":32},{"date":494,"type":32},"2024-05-06",{"date":496,"type":21},"2027-05-05",{"name":38,"class":39},373,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":522},"100647498","phase-1-dareon-36-a-study-to-test-obrixtamig-in-combination-with-zl-1310-in-people-with-advanced-small-cell-lung-cancer-or-other-neuroendocrine-cancers-100647498","NCT07707895","DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers","A Phase Ib\u002FII, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC","Inclusion criteria:\n\nFor Part 1\n\n1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:\n\n   * Small cell lung carcinoma (SCLC)\n   * Large cell neuroendocrine lung carcinoma (LCNEC-L)\n   * Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology\n2. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma\u002Fsmall cell component is predominant and represents at least 50% of the overall tumour tissue\n3. Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy, unless there is a documented medical reason not to use platinum\n\n   For Part 2\n4. Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme.\n5. Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible\n\n   For both Part 1 and Part 2\n6. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses\n7. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)\n8. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions\n9. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs\n2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer\n3. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement\n5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents\n6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment)\n7. Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy.\n8. Prior organ or tissue allograft\n9. Further exclusion criteria apply.",{"count":507,"type":21},60,[51,52],"This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.\n\nIn Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.\n\nThe study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.",[511,512,513,514],"Small Cell Lung Cancer","Large Cell Neuroendocrine Lung Carcinoma","Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology","Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology","2026-08-18",{"date":260,"type":32},{"date":518,"type":21},"2026-09-24",{"date":520,"type":21},"2030-04-26",{"name":38,"class":39},26,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":530,"sex":531,"minAge":18,"maxAge":532,"enrollmentInfo":533,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":281,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":543,"locationsCount":4},"100647305","phase-1-a-study-to-test-how-bi-3034701-is-taken-up-and-processed-by-the-body-in-healthy-men-with-normal-weight-or-overweight-100647305","NCT07708493","A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or Overweight","A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 3034701 (C-14) Administered to (Otherwise) Healthy Male Volunteers With Normal Body Weight or Overweight","Inclusion criteria:\n\n1. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests\n2. Age of 18 to 65 years (inclusive)\n3. Body mass index of 23.0 to 34.9 kg\u002Fm2 (inclusive)\n4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial\n\nExclusion criteria:\n\n1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator\n2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n5. Further exclusion criteria apply.",true,"MALE","65 Years",{"count":534,"type":21},8,[51],"The main objectives of this trial are:\n\nTo assess the mass balance (total recovery of \\[14C\\]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.",[538],"Healthy",{"date":260,"type":32},{"date":34,"type":21},{"date":542,"type":21},"2026-10-14",{"name":38,"class":39},""]