[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eli Lilly and Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":586},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,126,0,25,[9,43,62,91,130,153,174,197,218,241,262,282,303,322,344,365,385,411,432,450,472,498,519,539,566],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643141","phase-2-a-chronic-pain-master-protocol-cpmp-a-study-of-ly4065967-in-participants-with-chronic-low-back-pain-100643141",false,"NCT07641504","A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain","Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Chronic Low Back Pain","BP07","Inclusion Criteria:\n\n* Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation\n* Have a body mass index at screening of ≤40 kilograms per meter squared (kg\u002Fm²).\n* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening\n\nExclusion Criteria:\n\n* Are pregnant or breastfeeding\n* Have used a therapeutic injection to the spine in the 3 months prior to screening\n* Are using a spinal cord stimulator or dorsal root ganglion stimulator\n* Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP\n* Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine\n* Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (\\>140 mm Hg) and diastolic BP\\>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator","ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.",[28,29],"Chronic Pain","Low Back Pain","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-08-12",{"date":38,"type":22},"2027-04",{"name":40,"class":41},"Eli Lilly and Company","INDUSTRY",37,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":42},"100642998","phase-2-a-chronic-pain-master-protocol-cpmp-a-study-of-ly4065967-in-participants-with-osteoarthritis-pain-100642998","NCT07641517","A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain","Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis","OA07","Inclusion Criteria:\n\n* Have presence of index knee pain for more than 12 weeks at screening\n* Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee\n* Have a body mass index ≤40 kilograms per meter squared (kg\u002Fm²) (inclusive)\n* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening\n\nExclusion Criteria:\n\n* Are pregnant or breastfeeding\n* Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening\n* Have presence of surgical hardware or other foreign body in the index knee\n* Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.\n* Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening\n* Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (\\>140 mm Hg) and diastolic BP\\>90 mm Hg) at screening\n* Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator","40 Years",{"count":21,"type":22},[25],"The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.",[56,28],"Osteoarthritis, Knee",{"date":33,"type":34},{"date":59,"type":34},"2026-06-25",{"date":38,"type":22},{"name":40,"class":41},{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":18,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100641216","phase-3-a-study-to-see-if-lepodisiran-can-reduce-plaque-in-coronary-arteries-of-adults-with-elevated-lpa-who-have-had-heart-events-or-are-at-high-risk-100641216","NCT07613294","A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event","ACCLAIM-CTA","Inclusion Criteria:\n\n* Have an Lp(a) ≥175 nmol\u002FL\n* Have established cardiovascular (CV) disease or are at risk for a first CV event\n* Have angiographic evidence of coronary artery disease on screening CCTA\n* If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks\n\nExclusion Criteria:\n\n* Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening\n* Have moderate to severe renal dysfunction\n* Have severe heart failure\n* Have a history of coronary artery bypass graft surgery (CABG)\n* Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention\n* Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)\n* Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical\u002Ftechnical factors","45 Years","80 Years",{"count":73,"type":22},252,[75],"PHASE3","Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).\n\nParticipation will last about 120 weeks.",[78,79,80],"Atherosclerosis","Cardiovascular Diseases","Lipoprotein(a)",[82,83],"CCTA","Coronary plaque burden",{"date":33,"type":34},{"date":86,"type":34},"2026-06-01",{"date":88,"type":22},"2029-12",{"name":40,"class":41},58,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":121,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100637347","phase-3-a-study-of-orforglipron-ly3502970-in-participants-with-type-2-diabetes-who-observe-ramadan-fasting-100637347","NCT07613307","A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting","A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)","ACHIEVE-RAM","Inclusion Criteria:\n\n* Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.\n* Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol\u002Fmol)) to less than 9.5% (91 mmol\u002Fmol) at screening.\n* Intend to be compliant with the fast during the Ramadan period.\n* Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.\n* Have body mass index (BMI) of 25 kilograms per meter square (kg\u002Fm2) or higher at screening.\n\nExclusion Criteria:\n\n* Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes\n* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of chronic or acute pancreatitis any time prior to screening\n* Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.\n* Have a history of cholecystectomy (surgically removed gallbladder)\n* Have New York Heart Association Functional Classification IV congestive heart-failure.","65 Years",{"count":101,"type":22},130,[75],"The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.",[105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"Diabetes Mellitus, Type 2","Diabetes Melletus","Glucose Metabolism Disorders","Metabolic Disorders","Nutritional and Metabolic Diseases","Endocrine System Diseases","Feeding Behavior","Behavior","Fasting","Glucagon-Like Peptide-1 Receptor","Glucagon-Like Peptide Receptors","Receptors, G-Protein-Coupled","Receptors, Cell Surface","Membrane Proteins","Proteins","Receptors, Peptide",[122,113],"Ramadan",{"date":33,"type":34},{"date":125,"type":34},"2026-07-15",{"date":127,"type":22},"2027-05",{"name":40,"class":41},40,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100635042","a-study-of-ly3971297-in-participants-with-heart-failure-100635042","NCT07547540","A Study of LY3971297 in Participants With Heart Failure","A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF","Inclusion Criteria:\n\n* Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening.\n* Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days.\n* Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study.\n* Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL\u002FMinute\u002F1.73m²) at screening.\n* Have systolic blood pressure (SBP) greater than (\\>) 110 millimeters of mercury (mmHg) at screening and at enrollment.\n* Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg\u002Fm²) (inclusive).\n* Are individuals assigned male or female at birth, who are not of childbearing potential.\n* Have venous access sufficient to allow blood sampling.\n* Applicable to heart failure with preserved ejection fraction (HFpEF) participants only\n\n  * Have left ventricular ejection fraction (LVEF) \\>45 percent (%).\n  * Left atrial volume index \\>34 milliliters per square meter (mL\u002Fm²) in participants in sinus rhythm, or \\>40 mL\u002Fm² in participants with atrial fibrillation (AF).\n  * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>300 picograms per milliliter (pg\u002FmL) for participants without AF or \\>850 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFpEF.\n* Applicable to heart failure with reduced ejection fraction (HFrEF) participants only:\n\n  * Have LVEF \\\u003C40% .\n  * NT-proBNP \\>600 pg\u002FmL for participants without AF or \\>900 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFrEF.\n\nExclusion Criteria:\n\n* Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy.\n* Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening.\n* Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and\u002For during screening period until randomization.\n* Have SBP ≥180 mmHg at screening.\n* Have symptomatic hypotension.\n* Have resting heart rate \\>90 beats per minute (bpm) at screening.\n* Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.\n* Have any history of moderate-to-severe stenosis of the mitral and\u002For aortic valve or severe mitral and\u002For aortic regurgitation.\n* Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation.\n* Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety.\n* Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period.\n* Have any history of greater than moderate pulmonary hypertension.\n* Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening.\n* Have severe chronic obstructive pulmonary disease (COPD).\n* Have clinically significant or uncontrolled cardiac arrhythmia.\n* Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests.\n* Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer).\n* For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.\n* For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months.\n* Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study.\n* Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study.\n* Participants must abstain from taking new prescription or nonprescription drugs.\n* Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators.\n* Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug.\n* Have BP and\u002For pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP).\n* Are diagnosed with orthostatic hypotension.\n* Show evidence of an acute infection with fever or infectious disease at screening.\n* Applicable to HFrEF participants only\n\n  * Have been listed for cardiac transplantation and\u002For anticipated or implanted ventricular assist device.\n  * Have received cardiac resynchronization therapy for less than 6 months.\n* Hospitalization for heart failure within 30 days of screening.",{"count":138,"type":22},90,[140],"PHASE1","The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.",[143,144,145],"Heart Failure","Heart Failure, Diastolic","Heart Failure, Systolic",{"date":33,"type":34},{"date":148,"type":34},"2026-08-11",{"date":150,"type":22},"2027-11",{"name":40,"class":41},12,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":90},"100625257","phase-2-a-study-of-brenipatide-in-participants-with-opioid-use-disorder-100625257","NCT07420283","A Study of Brenipatide in Participants With Opioid Use Disorder","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)","RENEW-Op-1","Inclusion Criteria:\n\n* Have a current mild, moderate or severe opioid use disorder (OUD)\n* Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to administer the study intervention\n  * store and use the provided study intervention as directed\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n* Are intermittently using non-legal, non-prescribed opioids\n* Are taking buprenorphine for treatment on OUD\n\nExclusion Criteria:\n\n* Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco use disorder, mild-to-moderate alcohol or mild-to-moderate cannabis use disorder\n\nNote: any level of caffeine use is allowed\n\n* Are actively suicidal or deemed a significant risk for suicide\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening\n* Had opioid overdose in past 6 months prior to screening\n* Have a lifetime history or current diagnosis of the following:\n\n  * schizophrenia or other psychotic disorder\n  * bipolar disorder\n  * borderline personality disorder\n  * any eating disorder\n* Have type 1 diabetes mellitus, or a history of ketoacidosis, or hyperosmolar state, or coma","75 Years",{"count":163,"type":22},465,[25],"The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.\n\nThe maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.",[167],"Opioid Use Disorder",{"date":33,"type":34},{"date":170,"type":34},"2026-02-13",{"date":172,"type":22},"2028-03",{"name":40,"class":41},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":71,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854","NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization",{"count":183,"type":22},1431,[25],"The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[187,188,189],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":33,"type":34},{"date":192,"type":34},"2026-03-26",{"date":194,"type":22},"2031-07",{"name":40,"class":41},259,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":217},"100624505","phase-2-a-study-of-brenipatide-in-adult-participants-with-schizophrenia-100624505","NCT07410507","A Study of Brenipatide in Adult Participants With Schizophrenia","A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)","RENEW-Scz-1","Inclusion Criteria:\n\n* Meet the diagnostic criteria of schizophrenia\n* Are on a stable standard of care medication regimen for schizophrenia\n* If the duration of illness is \\>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years\n* Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention store and use the provided study intervention as directed,\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n\nExclusion Criteria:\n\n* Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder\n* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening\n* Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma\n* Are actively suicidal or deemed to be a significant risk for suicide\n* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study","55 Years",{"count":207,"type":22},450,[25],"The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.\n\nThe trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.",[211],"Schizophrenia",{"date":33,"type":34},{"date":214,"type":34},"2026-02-10",{"date":150,"type":22},{"name":40,"class":41},103,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100623096","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-persistent-obesity-who-are-treated-with-a-weekly-incretin-100623096","NCT07392190","A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes","ENLIGHTEN-6","Inclusion Criteria:\n\n* Are on stable incretin therapy at screening\n* With persistent obesity or overweight defined as:\n\n  * ≥30 kg\u002Fm2 OR\n  * ≥27 kg\u002Fm2 with at least one existing obesity related complication at screening:\n\n    * hypertension\n    * dyslipidemia\n    * obstructive sleep apnea\n    * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or\n    * type 2 diabetes\n* Have a stable body weight (\\\u003C5% body weight change) at screening\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* Have type 1 diabetes\n* Have taken any of the following antihyperglycemic medications within 90 days before screening:\n\n  * dipeptidyl peptidase-4 (DPP-4) inhibitors\n  * amylin analogs\n  * insulin\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * 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",{"count":227,"type":22},900,[75],"The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.\n\nParticipation in the study will last about 80 weeks.",[231,232],"Overweight","Obesity",[234],"Amylin receptor agonist",{"date":33,"type":34},{"date":214,"type":34},{"date":238,"type":22},"2028-07",{"name":40,"class":41},187,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100620154","phase-3-efficacy-and-safety-of-eloralintide-ly3841136-in-participants-with-osteoarthritis-knee-pain-and-obesity-or-overweight-100620154","NCT07353931","Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain 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 Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)","ENLIGHTEN-4","Inclusion Criteria:\n\n* Have a body mass index (BMI) of 27 kilograms per square meter (kg\u002Fm²) or higher at screening\n* Have a stable body weight (less than 5% body weight change) for 90 days prior to screening\n* Have tried at least once to lose weight through diet but were unsuccessful\n* Have osteoarthritis of the knee and at least one of the following conditions:\n\n  * Be over 50 years old\n  * Have morning knee stiffness that lasts about 30 minutes\n  * Have a crackling or grinding sound or feeling in the knee\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 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* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n* Have an active knee infection\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * 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":227,"type":22},[75],"The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.",[253,254],"Osteoarthritis","Overweight or Obesity",{"date":33,"type":34},{"date":257,"type":34},"2026-02-09",{"date":259,"type":22},"2028-05",{"name":40,"class":41},152,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100617689","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obesity-or-overweight-without-type-2-diabetes-100617689","NCT07321886","A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes","ENLIGHTEN-1","Inclusion Criteria:\n\n* Have Body Mass Index (BMI) at screening of the following:\n\n  * 30 kilogram per square meter (kg\u002Fm2) OR\n  * 27 kg\u002Fm2 with at least one of the following weight-related health conditions at screening:\n\n    * high blood pressure\n    * dyslipidemia\n    * obstructive sleep apnea, or\n    * heart disease\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\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* Have type 1 diabetes or type 2 diabetes\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * 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":271,"type":22},1980,[75],"The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.\n\nParticipation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.",[232,231],{"date":33,"type":34},{"date":277,"type":34},"2026-02-06",{"date":279,"type":22},"2030-07",{"name":40,"class":41},162,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":290,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":301,"locationsCount":302},"100615015","phase-2-a-study-of-imlunestrant-ly3484356-in-premenopausal-women-with-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-2-negative-her2--early-breast-cancer-100615015","NCT07287098","A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer","preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer","preEMBER","Inclusion Criteria:\n\nCohort 1:\n\n* Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10%\n* Be willing and able to provide pre- and on-treatment tumor samples.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women.\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nCohort 2:\n\n* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis\n* Have undergone definitive loco-regional therapy.\n* Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nExclusion Criteria:\n\nCohort 1:\n\n* Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy.\n* Have had any prior therapy for an invasive or non-invasive breast cancer.\n* Have had prior radiotherapy to the ipsilateral chest wall for any malignancy.\n* Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer.\n* Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization.\n* Receiving current exogenous reproductive hormone therapy\n\nCohort 2:\n\n* Have ovarian cyst(s) greater than (\\>) 1 centimeter (cm) at screening.\n* Have metastatic occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Completed or discontinued prior adjuvant ET \\>6 months prior to screening.\n* Have received prior therapy with any selective estrogen receptor degrader (SERD).\n* Receiving current exogenous reproductive hormone therapy.","FEMALE",{"count":292,"type":22},600,[25],"This study will include two groups of patients: Cohort 1 and Cohort 2.\n\nCohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days.\n\nCohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.",[296],"Breast Neoplasms",{"date":33,"type":34},{"date":299,"type":34},"2026-05-13",{"date":88,"type":22},{"name":40,"class":41},89,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":321},"100614944","phase-2-a-study-of-brenipatide-in-adult-participants-with-bipolar-disorder-renew-bipolar-1-100614944","NCT07286175","A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)","A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)","Inclusion Criteria:\n\n* Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires\n* Are on stable standard of care medication for bipolar disorder\n\nExclusion Criteria:\n\n* Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:\n\n  * schizophrenia or other psychotic disorder\n  * borderline personality disorder, or\n  * any eating disorder\n* Have type 1 diabetes mellitus, or a history of\n\n  * ketoacidosis, or\n  * hyperosmolar state or coma\n* Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening\n* Are actively suicidal and or deemed to be at significant risk for suicide\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening",{"count":311,"type":22},400,[25],"The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.\n\nThe trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.",[315],"Bipolar Disorder",{"date":33,"type":34},{"date":318,"type":34},"2025-11-24",{"date":150,"type":22},{"name":40,"class":41},87,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100614669","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obesity-or-overweight-and-type-2-diabetes-100614669","NCT07282600","A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, and Type 2 Diabetes","ENLIGHTEN-2","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Are on stable treatment for type 2 diabetes for at least 90 days prior to screening\n* Have a BMI ≥ 27 kg\u002Fm2\n* Have a stable body weight (\\\u003C5% body weight change) for 90 days prior to screening\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* Have type 1 diabetes\n* Have taken any of the following antihyperglycemic medications within 90 days before screening:\n\n  * amylin analogs\n  * glucagon-like peptide-1 (GLP-1) receptor agonists\n  * glucose-dependent insulinotropic polypeptide\u002Fglucagon-like peptide-1 (GIP\u002FGLP) receptor agonists, or\n  * insulin\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * 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":331,"type":22},1035,[75],"The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.",[231,232],[336],"Type 2 Diabetes",{"date":33,"type":34},{"date":339,"type":34},"2025-12-15",{"date":341,"type":22},"2028-02",{"name":40,"class":41},159,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100610150","phase-2-a-study-of-brenipatide-in-adults-who-quit-smoking-cigarettes-and-want-to-avoid-relapse-100610150","NCT07223840","A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse","A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)","RENEW-Smk-1","Inclusion Criteria:\n\n* Have recently quit smoking and are motivated to stay quit from smoking\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits and are willing and able to follow study procedures as required, such as self-inject study intervention\n\nExclusion Criteria:\n\n* Have evidence of any substance use disorder within the past 180 days prior to screening, except mild alcohol use disorder, mild cannabis use disorder, or tobacco use disorder\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the C-SSRS and the ideation occurred within the past 6 months, or have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have severe chronic obstructive pulmonary disease, or any other clinically severe respiratory condition that in the investigator's opinion may pose a risk.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening",{"count":353,"type":22},222,[25],"This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit.\n\nStudy participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period.",[357],"Smoking",{"date":33,"type":34},{"date":360,"type":34},"2025-11-03",{"date":362,"type":22},"2027-02",{"name":40,"class":41},29,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":343},"100610131","phase-3-efficacy-and-safety-of-orforglipron-in-participants-with-peripheral-artery-disease-100610131","NCT07223593","Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease","A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial","ATTAIN-PAD","Inclusion Criteria:\n\n* Have symptomatic PAD with intermittent claudication of Fontaine Stage II\n* Have an Ankle Brachial Index (ABI) of 0.9 or less\n\nExclusion Criteria:\n\n* Have a body mass index (BMI) less than 23 kilogram per square meter (kg\u002Fm2)\n* Have Hemoglobin A1c (HbA1c) greater than 10%\n* Have walking ability limited by conditions other than PAD\n* Have a planned lower limb surgery or any other surgery affecting walking ability\n* Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial\n* Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening\n* Have heart failure presently classified as being in New York Heart Association class III - IV",{"count":374,"type":22},1205,[75],"The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.",[378],"Peripheral Arterial Disease",{"date":33,"type":34},{"date":381,"type":34},"2025-10-31",{"date":383,"type":22},"2028-06",{"name":40,"class":41},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":409,"locationsCount":410},"100610034","phase-3-a-study-of-baricitinib-ly3009104-to-preserve-beta-cell-function-in-children-and-adults-newly-diagnosed-with-type-1-diabetes-baricade-preserve-100610034","NCT07222332","A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to \u003C36 Years","Inclusion Criteria:\n\n* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention\n* Have at least one diabetes-related autoantibody found at screening\n* Show signs of remaining beta-cell function\n\n  * stimulated (peak or 90 min) C-peptide ≥0.2 nmol\u002FL (0.6 ng\u002FmL) at screening\n* Weigh at least 8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes including gestational\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious medical condition or infection","1 Year","35 Years",{"count":395,"type":22},300,[75],"The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.",[399],"Diabetes Mellitus, Type 1",[401,402,403,404],"T1DM","Children","New-onset","Beta-cell Function",{"date":33,"type":34},{"date":407,"type":34},"2026-02-05",{"date":238,"type":22},{"name":40,"class":41},138,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100609852","phase-3-a-study-of-brenipatide-in-participants-with-moderate-to-severe-alcohol-use-disorder-100609852","NCT07219966","A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder","A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)","RENEW-ALC-1","Inclusion Criteria:\n\n* Participant must be a minimum of 20 years of age for the investigative sites in Japan.\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have either of the following:\n\n  * history of advanced liver disease, including advanced liver fibrosis \\[Stage 3\\] or cirrhosis \\[Stage 4\\], based on prior biomarkers, imaging or liver biopsy, OR\n  * history of acute alcohol-associated hepatitis based on prior liver biopsy.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).",{"count":420,"type":22},1100,[75],"The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.",[424],"Alcohol Use Disorder",{"date":33,"type":34},{"date":427,"type":34},"2025-10-15",{"date":429,"type":22},"2028-04",{"name":40,"class":41},118,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":449},"100609851","phase-3-a-study-of-brenipatide-in-participants-with-alcohol-use-disorder-100609851","NCT07219953","A Study of Brenipatide in Participants With Alcohol Use Disorder","A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)","RENEW-ALC-2","Inclusion Criteria:\n\n* Participant must be a minimum of 20 years of age for the investigative sites in Japan.\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention.\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have either of the following:\n\n  * history of advanced liver disease, including advanced liver fibrosis \\[Stage 3\\] or cirrhosis \\[Stage 4\\], based on prior biomarkers, imaging or liver biopsy, OR\n  * history of acute or alcohol-associated hepatitis based on prior liver biopsy.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).",{"count":420,"type":22},[75],"The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.",[424],{"date":33,"type":34},{"date":446,"type":34},"2025-10-16",{"date":429,"type":22},{"name":40,"class":41},116,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":471},"100609791","phase-2-a-study-to-evaluate-brenipatide-compared-with-placebo-in-adult-participants-with-uncontrolled-moderate-to-severe-asthma-100609791","NCT07219173","A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma","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 Uncontrolled Moderate to Severe Asthma","RENEW-Asthma","Inclusion Criteria:\n\n* Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.\n* Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.\n* History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  * An established diagnosis of occupational asthma\n* Known pre-existing, clinically important lung condition other than asthma, including but not limited to:\n\n  * chronic respiratory infection\n  * bronchiectasis\n  * pulmonary fibrosis\n  * allergic bronchopulmonary aspergillosis\n  * emphysema\n  * chronic bronchitis\n  * eosinophilic granulomatosis with polyangiitis\n  * chronic obstructive pulmonary disease, and\n  * other mimics of asthma, that is, vocal cord dysfunction.\n* Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.",{"count":459,"type":22},531,[25],"The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.\n\nStudy participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.",[463],"Asthma",[465],"Incretin",{"date":33,"type":34},{"date":468,"type":34},"2025-10-22",{"date":383,"type":22},{"name":40,"class":41},121,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":487,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":497},"100609730","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100609730","NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.",{"count":207,"type":22},[75],"The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[484,485,486],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[488,489,490],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma",{"date":33,"type":34},{"date":493,"type":34},"2025-12-12",{"date":495,"type":22},"2033-05",{"name":40,"class":41},290,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100609727","phase-4-a-study-of-pirtobrutinib-ly3527727-in-participants-with-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100609727","NCT07218341","A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Are actively participating in study J2N-MC-JZNN\u002FLOXO-BTK-20020\n\nExclusion Criteria:\n\n* This is not applicable to this study",{"count":21,"type":22},[507],"PHASE4","This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN\u002FLOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.",[510,511],"Chronic Lymphocytic Leukemia","Lymphoma, Small Lymphocytic",{"date":33,"type":34},{"date":514,"type":34},"2026-03-09",{"date":516,"type":22},"2032-12",{"name":40,"class":41},50,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":161,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":536,"leadSponsor":537,"locationsCount":538},"100609513","phase-2-a-study-of-macupatide-ly3532226-and-eloralintide-ly3841136-alone-or-in-combination-in-adults-with-obesity-or-overweight-and-with-type-2-diabetes-100609513","NCT07215559","A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes","A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have an HbA1c ≥7.5% to ≤10.5% at screening\n* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening\n\n  * Diet and exercise\n  * Stable dose of metformin\n  * Sodium-glucose cotransporter-2 (SGLT2) inhibitor\n* Have had a stable body weight (\\\u003C5% body weight gain and\u002For loss) for the 3 months prior to screening\n* Have a BMI of 27 or greater at screening\n\nExclusion Criteria:\n\n* Have any form of diabetes other than type 2 diabetes\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening\n* Have any of the following cardiovascular conditions within 3 months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include\n\n  * basal or squamous cell skin cancer\n  * in situ carcinomas of the cervix, or\n  * in situ prostate cancer\n* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:\n\n  * amylin RA\n  * dual amylin and calcitonin RA\n  * glucagon-like peptide-1 receptor (GLP-1) RA\n  * glucose-dependent insulinotropic peptide (GIP)\u002FGLP-1 RA\n  * GLP-1\u002Fglucagon (GCG) RAs, or\n  * GIP\u002FGLP-1\u002FGCG RAs\n* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides\n* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed",{"count":527,"type":22},200,[25],"The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.",[232,231,105],[532,533],"GIP","Amylin",{"date":33,"type":34},{"date":446,"type":34},{"date":127,"type":22},{"name":40,"class":41},42,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":555,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100609378","phase-3-a-three-part-phase-3-study-of-sofetabart-mipitecan-in-participants-with-platinum-resistant-part-a-and-platinum-sensitive-parts-b-and-c-ovarian-cancer-100609378","NCT07213804","A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer","FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.","FRAmework-01","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n* Have confirmed availability of tumor tissue block or slides\n* Have radiographic progression on or after most recent line of systemic anticancer therapy\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Have measurable disease per RECIST v1.1\n\nPart A:\n\n* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.\n* Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.\n* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.\n* Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.\n\nPart B and C:\n\n* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\\>)6 months of their last administration of platinum therapy\n* Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy\n\nPart B:\n\n\\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.\n\nPart C:\n\n\\- Have not previously received a PARPi treatment.\n\nExclusion Criteria:\n\nParts A, B and C:\n\n\\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.\n\nPart A:\n\n* Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.\n\nPart B and C:\n\n\\- Have clinically significant proteinuria\n\nPart C:\n\n\\- Have a known pathogenic BRCA1\u002F2 gene alteration (somatic or germline).",{"count":548,"type":22},1630,[75],"This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.",[552,553,554,486],"Ovarian Neoplasms","Fallopian Tube Neoplasms","Peritoneal Neoplasms",[556,557,558,559],"Folate Receptor Alpha","Antibody-drug Conjugate","Platinum-Resistant","Platinum-Sensitive",{"date":33,"type":34},{"date":468,"type":34},{"date":563,"type":22},"2031-08",{"name":40,"class":41},268,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":71,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100607249","phase-2-ly4268989-morf-057-co-administered-with-mirikizumab-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100607249","NCT07186101","LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:","A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis","TOPAZ-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC\n* Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.\n* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization\n* Are up-to-date on colorectal cancer surveillance per local society guidelines\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:\n* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)\n\nNOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)\n\n* Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:\n\n  * a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12\u002F23, or IL-23p19), except for\n\n    * mirikizumab.\n  * Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib\n  * sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed\n\nNote: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply\n\n* Have a current or recent acute, active infection",{"count":73,"type":22},[25],"The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).\n\nStudy participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.",[578],"Ulcerative Colitis",{"date":33,"type":34},{"date":581,"type":34},"2025-11-10",{"date":583,"type":22},"2029-03",{"name":40,"class":41},147,""]