[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,796,0,25,[9,39,76,106,131,170,197,228,256,285,307,333,364,393,421,445,466,486,509,535,560,583,604,626,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100639662","a-study-to-identify-and-characterize-patients-with-type-2-diabetes-mellitus-for-possible-participation-in-ongoing-or-future-type-2-diabetes-mellitus-clinical-studies-100639662",false,"NCT07606066","A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age at the time of signing the ICF.\n* Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World\n\nHealth Organization or local diagnostic standards, inadequately managed with:\n\n1. Lifestyle management alone, AND\u002FOR\n2. A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF.\n\n   * Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required.\n   * Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis.\n\nExclusion Criteria:\n\n* Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol).\n* Diagnosed with Type 1 diabetes mellitus.\n* Known pregnancy at the time of visit or having the intention to become pregnant.","ALL","18 Years",{"count":19,"type":20},2150,"ESTIMATED","1 Day","OBSERVATIONAL","The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.",[25],"Type 2 Diabetes","RECRUITING","2026-08-24",{"date":29,"type":30},"2026-08-25","ACTUAL",{"date":32,"type":30},"2026-05-06",{"date":34,"type":20},"2027-03-31",{"name":36,"class":37},"AstraZeneca","INDUSTRY",76,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":47,"type":20},500,"INTERVENTIONAL",[50,51],"PHASE2","PHASE3","A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[54],"Non-Small Cell Lung Cancer",[56,57,58,59,60,61,62,63,64,65,66,67],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed",{"date":29,"type":30},{"date":70,"type":30},"2025-11-05",{"date":72,"type":20},"2030-11-15",{"name":74,"class":37},"Bristol-Myers Squibb",186,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":48,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":85,"type":20},590,[50,51],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[89],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[91,92,93,94,95,96,97,98],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":29,"type":30},{"date":101,"type":30},"2026-01-02",{"date":103,"type":20},"2031-08-12",{"name":74,"class":37},320,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":48,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":115,"type":20},450,[51],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[119],"Bipolar Disorder Type I With Mania",[121,122,123],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":29,"type":30},{"date":126,"type":30},"2025-07-18",{"date":128,"type":20},"2028-06-13",{"name":74,"class":37},174,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":139,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":48,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","100 Years",{"count":142,"type":20},940,[51],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[146],"Prostate Cancer",[148,149,150,151,152,153,154,155,156,157,158,159,137,160,161],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":29,"type":30},{"date":164,"type":30},"2025-07-01",{"date":166,"type":20},"2032-11-04",{"name":168,"class":37},"Novartis Pharmaceuticals",93,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":178,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":48,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE","15 Years",{"count":181,"type":20},800,[51],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[185],"Locally Advanced Cervical Cancer",[187,188,189],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":29,"type":30},{"date":192,"type":30},"2023-09-22",{"date":194,"type":20},"2030-09-30",{"name":36,"class":37},205,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":205,"targetDuration":4,"studyType":48,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":206,"type":20},1400,[51],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[210],"Early Breast Cancer",[212,213,214,215,216,217,218,219,220],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":29,"type":30},{"date":223,"type":30},"2024-02-28",{"date":225,"type":20},"2030-09-20",{"name":168,"class":37},228,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":48,"phases":237,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":255},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":236,"type":20},626,[50,51],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[240,241],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[243,244,93,241,245,246,247],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":29,"type":30},{"date":250,"type":30},"2020-12-02",{"date":252,"type":20},"2029-10-31",{"name":254,"class":37},"Mirati Therapeutics Inc.",770,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":178,"minAge":17,"maxAge":113,"enrollmentInfo":264,"targetDuration":4,"studyType":48,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100644031","phase-3-nuvastatic-phase-iii-trial-for-fatigue-in-triple-negative-breast-cancer-100644031","NCT07669467","Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy","NuvastaticTM","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.\n* Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.\n* Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.\n* Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.\n* The patient has stable haemoglobin (≥ 9 g\u002FdL) throughout the screening.\n* Life expectancy ≥ 6 months, as per the investigator's judgment.\n* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.\n* At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.\n\nExclusion Criteria:\n\n* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.\n* Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.\n* Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.\n* Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.\n* Patients with known central nervous system (CNS) involvement.\n* Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.\n* Female patients who are pregnant or breastfeeding.\n* Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n* Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.\n* Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.\n* Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.\n* Patients with planned therapy or treatment with another investigational agent.\n* Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an investigational agent, other than as specified by this protocol, during the study period.",{"count":265,"type":20},250,[51],"The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\n* Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?\n* Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\n* Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \\~60 treatment days).\n* Continue their standard first-line chemotherapy regimen.\n* Provide blood sample assessments at Screening and End of Treatment.\n* Complete patient diaries and fatigue assessments as per protocol.",[269,270],"Fatigue Related to Cancer Treatment","Breast Cancer",[272,270,273,274,275],"Nuvastatic","Cancer related fatigue","Randomized double blind placebo controlled trail","First-Line Chemotherapy","2026-08-23",{"date":29,"type":30},{"date":279,"type":30},"2025-10-01",{"date":281,"type":20},"2026-10-30",{"name":283,"class":37},"Natureceuticals Sdn Bhd",6,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":262,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":292,"targetDuration":4,"studyType":48,"phases":294,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":306,"locationsCount":284},"100643932","phase-3-evaluation-of-nuvastatictm-in-reducing-cancer-related-fatigue-in-stage-iv-colon-cancer-patients-undergoing-first-line-chemotherapy-100643932","NCT07669519","Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy","Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy","Inclusion Criteria:\n\n1. Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.\n2. Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.\n3. Patients must have a confirmed diagnosis of colon cancer as per standard guideline.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.\n5. The patient has stable haemoglobin (≥ 9 g\u002FdL) throughout the screening.\n6. Life expectancy ≥ 6 months, as per Investigator's judgment\n7. Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deemed stable by the investigator can be included in the study\n8. At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.\n9. Starting first-line chemo\n\nExclusion Criteria:\n\n1. Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator's clinical judgment.\n2. Patients who have stage IV Disease\n3. Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug.\n4. Prior metastatic chemo, targeted\u002Fimmunotherapy, severe comorbidities\n5. Female patients who are pregnant or breast-feeding.\n6. Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n7. Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the Investigator.\n8. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '\n9. Patients with planned therapy or treatment with another investigational agent.\n10. Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.",{"count":293,"type":20},180,[51],"The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\nDoes Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\nReceive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \\~60 treatment days).\n\nContinue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment.\n\nComplete patient diaries and fatigue assessments as per protocol.",[297,298],"Fatigue","Colon Cancer",[298,300,272,301,275],"Cancer-Related Fatigue","Randomized Double-Blind Placebo-Controlled Trial",{"date":29,"type":30},{"date":304,"type":30},"2025-08-18",{"date":34,"type":20},{"name":283,"class":37},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":48,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100653263","phase-3-a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-without-type-2-diabetes-mellitus-100653263","NCT07784725","A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)","SELENE 1","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥30 kg\u002Fm2 OR BMI ≥27 kg\u002Fm2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol\u002Fmol), and\u002For treatment with glucose-lowering agent(s) within 3 months prior to Screening\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.",{"count":316,"type":20},2500,[51],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment",[320],"Obesity or Overweight",[322,323,324],"Obesity","Overweight","AZD6234","2026-08-21",{"date":29,"type":30},{"date":328,"type":30},"2026-08-19",{"date":330,"type":20},"2029-05-21",{"name":36,"class":37},212,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":48,"phases":344,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":363},"100653204","home-based-functional-electrical-stimulation-for-lower-limb-rehabilitation-in-stroke-patients-100653204","NCT07785700","Home-Based Functional Electrical Stimulation for Lower Limb Rehabilitation in Stroke Patients.","Feasibility and Effectiveness of Home-Based Functional Electrical Stimulation (FES) for Lower Limb Rehabilitation in Post-Stroke Individuals","FES","Inclusion Criteria:\n\n1. Age ≥ 18 years with ischemic or hemorrhagic stroke (one month to one year post stroke)\n2. Clinical evidence of mild to moderate lower-limb weakness, defined as Manual Muscle Test (MMT) grade 2 or 3 in one or more target muscle groups (e.g., tibialis anterior, quadriceps, hamstrings) on the affected side.\n3. Cognitively able to follow instructions and provide informed consent (e.g., MMSE ≥ 24 or equivalent screening, or judged capable by the investigator).\n4. Access to a compatible smartphone and home internet service and willing\u002Fable to use the tele-rehab app.\n5. Skin at electrode application sites intact (no open wounds) and no dermatologic condition that would prevent safe application of the sleeve.\n\nExclusion Criteria:\n\n1. Implanted electronic medical device contraindicated with FES (e.g., pacemaker, implantable cardioverter-defibrillator) or other metallic implants near stimulation site that the treating clinician deems a contraindication.\n2. Active seizure disorder (epilepsy) that is uncontrolled or where stimulation could increase seizure risk, diabetes mellitus.\n3. Pregnancy or breastfeeding.\n4. Known allergy to materials used in the FES sleeve or electrodes.\n5. Severe spasticity in target muscle groups (e.g., Modified Ashworth Scale ≥ 3) that prevents functional stimulation or safe participation.\n6. Severe cardiovascular instability or uncontrolled medical conditions that make participation unsafe (e.g., unstable angina, recent myocardial infarction within 3 months, uncontrolled hypertension-systolic \\>180 mmHg or diastolic \\>110 mmHg at screening).\n7. Severe cognitive impairment, active psychiatric illness, or communication barriers that preclude safe device use or reliable consent\u002Fassessment.\n8. Open wounds, skin infection, severe dermatitis, or other skin conditions at electrode or sleeve contact sites.\n9. Participation in another interventional trial that would conflict with outcomes or safety reporting for this sub study.","99 Years",{"count":343,"type":20},70,[345],"NA","This assessor-blinded, randomized, parallel-group feasibility trial will evaluate the feasibility and preliminary effectiveness of a home-based Functional Electrical Stimulation (FES) system for lower-limb rehabilitation in adults recovering from stroke. The study will be conducted at two sites within the INSTRUCT Network in India.\n\nAdults aged 18 years or older who are 1 month to 1 year post-stroke and have mild to moderate lower-limb weakness will be eligible to participate. A total of 70 participants will be randomly allocated in a 1:1 ratio to either a home-based FES intervention group or a control group receiving standard rehabilitation.\n\nParticipants in the FES group will receive training on safe and independent use of the FES device before commencing home treatment. FES will be delivered to selected lower-limb muscles, including the quadriceps, tibialis anterior, and hamstrings, for 30 minutes per session, 5 sessions per week, for 12 weeks. The intervention will be supported by a smartphone-based telerehabilitation platform that will provide remote clinician support, training, adherence monitoring, and troubleshooting. The FES system is being developed with IoT-enabled monitoring and ECG-based heart-rate safety monitoring to facilitate safe home use.\n\nParticipants in the control group will receive standard outpatient care and home-based rehabilitation without FES. Both groups will receive equivalent remote clinician contact and education.\n\nThe primary purpose of the study is to determine the feasibility of home-based FES, including recruitment, retention, adherence to prescribed treatment sessions, safety, and participants' ability to independently operate the device at home. Secondary evaluation will assess preliminary changes in functional walking ability using the 6-Minute Walk Test (6MWT), measured at baseline and after 12 weeks.\n\nThe study is intended to generate feasibility and preliminary effectiveness data to inform the design of a future, adequately powered randomized controlled trial and to assess the potential for wider implementation of home-based FES rehabilitation for people recovering from stroke.",[348],"Stroke",[350,351,352,353],"Lower limb dysfunction","Gait Impairment","Post Stroke Rehabilitation","Functional Electrical Stimulation","NOT_YET_RECRUITING",{"date":29,"type":30},{"date":357,"type":20},"2027-01-01",{"date":359,"type":20},"2030-12-31",{"name":361,"class":362},"Christian Medical College and Hospital, Ludhiana, India","OTHER",1,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":16,"minAge":371,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":48,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100652673","phase-3-open-label-phase-3b-study-to-evaluate-the-long-term-efficacy-and-safety-of-lerodalcibep-in-children-and-adolescents-6-to-17-years-of-age-with-heterozygous-familial-hypercholesterolemia-on-stable-diet-and-oral-lipid-lowering-therapy-100652673","NCT07775339","Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia (LIBerate-Kids OLE)","Inclusion Criteria:\n\n1. Provision of written and signed informed consent\u002Fassent of the LIB003-016 trial prior to any study-specific procedure;\n2. Completion of the LIB003-008 study having received the last dose of study drug at Week 20 and completed the Week 24 visit;\n3. Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit of the LIB003-008 study;\n4. Weight of \\>18 kg (40 lbs) and BMI \\\u003C17 and \\>42 kg\u002Fm2;\n5. On stable diet and lipid-lowering oral drug therapy (statins, ezetimibe, bile-acid sequestrants) or combinations thereof (excluded oral lipid-lowering agents are include mipomersen, lomitapide, and gemfibrozil);\n\nExclusion Criteria:\n\n1. History of any prior or active clinical condition or acute and\u002For unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;\n2. Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception during the study and until 60 days after last dose of study drug, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;\n3. Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;\n4. A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;\n5. Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;","6 Years","17 Years",{"count":374,"type":20},150,[51],"The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)\u002Fpre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial.\n\nThe main question\\[s\\] it aims to answer are:\n\nHow effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns?\n\nParticipants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.",[378],"Heterozygous Familial Hypercholesterolemia (HeFH)",[380,381,382,383,384],"PCSK9 inhibitor","LDL-C","HeFH","lerodalcibep","pediatric",{"date":29,"type":30},{"date":387,"type":20},"2027-01-20",{"date":389,"type":20},"2031-12-31",{"name":391,"class":37},"LIB Therapeutics LLC",5,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":16,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":48,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years","75 Years",{"count":404,"type":20},606,[50],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[408],"Pulmonary Disease, Chronic Obstructive",[410,411,412],"Emphysema","Chronic Bronchitis","Lung Disease",{"date":27,"type":30},{"date":415,"type":20},"2026-08",{"date":417,"type":20},"2028-11",{"name":419,"class":37},"Eli Lilly and Company",128,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":48,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":444},"100645337","phase-3-study-of-izalontamab-brengitecan-bms-986507-in-combination-with-osimertinib-versus-osimertinib-monotherapy-or-osimertinib-in-combination-with-platinum-based-chemotherapy-for-egfrmt-non-small-cell-lung-cancer-izabright-lung02-100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":429,"type":20},850,[51],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[54],[93,434,435,62,58,436,437],"EGFR","First line","ADC","IZABRIGHT-Lung02",{"date":27,"type":30},{"date":440,"type":20},"2026-09-30",{"date":442,"type":20},"2031-12-30",{"name":74,"class":37},208,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":48,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":465},"100643877","phase-3-amaze-13-a-research-study-investigating-how-well-the-medicine-zenagamtide-helps-people-in-asia-with-excess-body-weight-lose-weight-100643877","NCT07668401","AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight","Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)","AMAZE 13","Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18 years or above at the time of signing the informed consent\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus.\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.",{"count":454,"type":20},400,[51],"The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.",[322,323],{"date":27,"type":30},{"date":460,"type":20},"2027-01-07",{"date":462,"type":20},"2029-01-11",{"name":464,"class":37},"Novo Nordisk A\u002FS",44,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":48,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100621314","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obstructive-sleep-apnea-and-obesity-or-overweight-100621314","NCT07369011","A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight","A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight","ENLIGHTEN-3","Inclusion Criteria:\n\n* Confirmed history of moderate-to-severe OSA\n* Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening\n* Have a BMI ≥27 kg\u002Fm2 at screening\n* Have a stable body weight (\\\u003C5% body weight change) for 90 days prior to screening\n* Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight\n\nFor YSA1 Participants:\n\n* Are unable or unwilling to use PAP therapy\n\nFor YSA2 Participants:\n\n* Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and\u002For device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening\n* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n* Have had within 90 days prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening",{"count":181,"type":20},[51],"The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.\n\nParticipants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.",[478,322,323],"Sleep Apnea, Obstructive",{"date":27,"type":30},{"date":481,"type":30},"2026-02-10",{"date":483,"type":20},"2028-04",{"name":419,"class":37},115,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":16,"minAge":493,"maxAge":372,"enrollmentInfo":494,"targetDuration":4,"studyType":48,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100614915","phase-3-a-study-of-karxt--karx-ec-for-treatment-of-irritability-in-children-and-adolescents-with-autism-spectrum-disorder-100614915","NCT07285798","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.","5 Years",{"count":495,"type":20},176,[51],"The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.",[499],"Irritability Associated With Autism Spectrum Disorder",[501],"Autism Spectrum Disorder",{"date":27,"type":30},{"date":504,"type":20},"2026-09-11",{"date":506,"type":20},"2029-08-06",{"name":74,"class":37},63,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":16,"minAge":516,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":48,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":534},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":518,"type":20},7140,[51],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[522,523],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[525,526,527,348],"Heart Disease","Kidney Disease","Outcomes",{"date":27,"type":30},{"date":530,"type":30},"2025-12-01",{"date":532,"type":20},"2031-08",{"name":419,"class":37},567,{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":402,"enrollmentInfo":543,"targetDuration":4,"studyType":48,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":559},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":544,"type":20},645,[50],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[548,549,550,551],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":29,"type":30},{"date":554,"type":30},"2025-05-27",{"date":556,"type":20},"2028-03",{"name":558,"class":37},"Spyre Therapeutics, Inc.",267,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":48,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":569,"type":20},15100,[51],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[573],"Cardiovascular Disease",[575],"Atherosclerotic Cardiovascular Disease",{"date":27,"type":30},{"date":578,"type":30},"2025-06-04",{"date":580,"type":20},"2029-10-26",{"name":36,"class":37},1452,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":48,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":603},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":592,"type":20},700,[51],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[596],"Carcinoma, Non-Small-Cell Lung",{"date":27,"type":30},{"date":599,"type":30},"2025-03-27",{"date":601,"type":20},"2032-02",{"name":419,"class":37},369,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":48,"phases":613,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":625},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":612,"type":20},211,[51],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[616,617],"Dermatomyositis","Polymyositis",{"date":29,"type":30},{"date":620,"type":30},"2025-01-22",{"date":622,"type":20},"2031-07-29",{"name":624,"class":37},"Pfizer",26,{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":16,"minAge":371,"maxAge":372,"enrollmentInfo":634,"targetDuration":4,"studyType":48,"phases":636,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":647},"100555499","phase-3-a-trial-to-investigate-benralizumab-in-children-with-eosinophilic-diseases-100555499","NCT06512883","A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases","Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)","CLIPS","Inclusion Criteria:\n\nAll Cohorts:\n\n* Male or female participants must be aged 6 to \\\u003C 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.\n* Body weight greater than (\\>=) 15 kilograms (kg).\n\nEGPA Cohort:\n\n* Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \\[\\>\\] 0.1 milligrams per kilogram per day (mg\u002Fkg\u002Fday), max dose of 50 milligrams per day (mg\u002Fday) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).\n* Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).\n\nHES Cohort:\n\n* Documented HES diagnosis, defined as history of persistent eosinophilia \\>1500 cells\u002FµL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement.\n* Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement.\n* AEC ≥1000 cells\u002FµL at screening (Visit 1).\n* Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation.\n\nExclusion Criteria:\n\nAll Cohorts:\n\n* Any current malignancy or history of malignancy.\n* History of anaphylaxis to any biologic therapy or vaccine.\n* Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.\n* Previous receipt of benralizumab in an interventional clinical study.\n\nEGPA Cohort:\n\n* Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.\n* EGPA relapse: any deterioration in EGPA and\u002For organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).\n* Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.\n\nHES Cohort:\n\n* Life-threatening HES or HES complications, as judged by the investigator.\n* Hypereosinophilia of unknown significance (HE-US).\n* Diagnosis of systemic mastocytosis.",{"count":635,"type":20},14,[51],"The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.",[639,640],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilia Syndrome (HES)",{"date":27,"type":30},{"date":643,"type":30},"2025-04-17",{"date":645,"type":20},"2029-05-14",{"name":36,"class":37},15,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":48,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":689},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":657,"type":20},1264,[51],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[596,661],"Neoplasm Metastasis",[240,663,664,665,666,667,668,669,670,671,672,673,674,661,54,675,61,676,677,678,679,680,681,682,60],"KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer (NSCLC)","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms",{"date":27,"type":30},{"date":685,"type":30},"2023-12-21",{"date":687,"type":20},"2031-01",{"name":419,"class":37},418,""]