[{"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:":556},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,132,0,25,[9,48,73,103,125,148,172,188,221,243,264,286,298,322,342,357,376,397,415,431,452,475,495,516,536],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764",false,"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.","ALL","18 Years",{"count":21,"type":22},450,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28,29,30],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[32,33,34],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-12-12",{"date":43,"type":22},"2033-05",{"name":45,"class":46},"Eli Lilly and Company","INDUSTRY",286,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100053263","phase-1-a-study-of-ly4178256-in-healthy-participants-100053263","NCT07698210","A Study of LY4178256 in Healthy Participants","A Phase 1, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4178256 in Healthy Participants","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures.\n* Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg\u002Fm²)\n* Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.\n\nExclusion Criteria:\n\n* Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.\n* Have abnormal blood pressure\n* Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (\\>450 msec) for males, or \\>470 msec for females.\n* Regularly use known drugs of abuse or with positive drug results (within the past 3 months).\n* Have a positive ethanol breath\u002Furine test result or positive urine drugs of abuse screen at screening or check-in.\n* Have hemoglobin level less than 12 grams per deciliter (\\\u003C12 g\u002FdL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (\\\u003C30 ng\u002FmL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.\n* Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.\n* Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR\\\u003C60mL\u002Fmin\u002F1.73 m ²)).",true,"65 Years",{"count":58,"type":22},88,[60],"PHASE1","The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.",[63],"Healthy Volunteers","NOT_YET_RECRUITING","2026-07-08",{"date":38,"type":39},{"date":68,"type":22},"2026-07",{"date":70,"type":22},"2028-02",{"name":45,"class":46},2,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"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":84,"type":22},252,[25],"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.",[88,89,90],"Atherosclerosis","Cardiovascular Diseases","Lipoprotein(a)",[92,93],"CCTA","Coronary plaque burden","2026-06-25",{"date":96,"type":39},"2026-06-29",{"date":98,"type":39},"2026-06-02",{"date":100,"type":22},"2029-04",{"name":45,"class":46},59,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":82,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100636859","phase-3-donanemab-ly3002813-trial-in-chinese-participants-with-cognitively-unimpaired-preclinical-alzheimers-disease-100636859","NCT07571161","Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease","A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease","Inclusion Criteria:\n\n* A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)\n* Clinical Dementia Rating-Global Score (CDR-GS) of 0\n* A plasma P-tau result consistent with amyloid pathology\n* A reliable study partner who:\n\n  * Provides written informed consent to participate in the study in their role\n  * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities\n  * Is of legal age (18 years of age or older) to consent\n  * Is available to conduct functional scales\n* Have adequate literacy, vision, and hearing for neuropsychological testing\n\nExclusion Criteria:\n\n* Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition\n* Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer\n* Have received active or passive immunization against amyloid beta (Aβ) in any other study\n* Have current or prior use of prescription medications for treatment of MCI or AD\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants\n* Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening","55 Years",{"count":112,"type":22},140,[25],"The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last up to approximately 156 weeks, excluding screening.",[116],"Alzheimer Disease",{"date":118,"type":39},"2026-06-26",{"date":120,"type":39},"2026-04-30",{"date":122,"type":22},"2030-04",{"name":45,"class":46},30,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":133,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"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":135,"type":22},600,[137],"PHASE2","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.",[140],"Breast Neoplasms",{"date":118,"type":39},{"date":143,"type":39},"2026-05-13",{"date":145,"type":22},"2029-12",{"name":45,"class":46},71,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100640230","phase-3-a-study-of-donanemab-ly3002813-in-participants-who-completed-study-aacm-trailblazer-alz-3-ext-100640230","NCT07602582","A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).","An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM","Inclusion Criteria:\n\n* Have completed study AACM Addendum 7.\n* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n* Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants\u002Fcardiac pacemaker.\n* Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.\n* Contraindication to florbetapir F 18 PET.\n* Have had history of amyloid-targeting therapy treatment outside donanemab trials.\n* Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.",{"count":156,"type":22},550,[25],"The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.",[116,160,161],"Dementia","Plaque, Amyloid",[163],"Donanemab","2026-06-24",{"date":118,"type":39},{"date":167,"type":39},"2026-05-22",{"date":169,"type":22},"2029-09",{"name":45,"class":46},58,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":187,"locationsCount":4},"100644897","expanded-access-for-vepugratinib-ly3866288-in-participants-with-fibroblast-growth-factor-receptor-3-fgfr3-altered-solid-tumors-100644897","NCT07675057","Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Expanded Access for Vepugratinib in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Inclusion Criteria:\n\n* Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.\n* Have exhausted other approved treatments, including erdafitinib for UC.\n* Are not eligible for an ongoing vepugratinib clinical trial\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study of vepugratinib\n* Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.\n* Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.\n* Significant cardiovascular disease:\n* Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.","EXPANDED_ACCESS","The treating physician\u002Finvestigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.",[29,30,28],[34],"AVAILABLE","2026-06-23",{"date":186,"type":39},"2026-06-30",{"name":45,"class":46},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":147},"100643997","phase-3-a-study-of-orforglipron-ly3502970-compared-with-dulaglutide-in-pediatric-participants-with-type-2-diabetes-100643997","NCT07668336","A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes","ACHIEVE-PEDS","Inclusion Criteria:\n\n* Have type 2 diabetes treated with diet and exercise and metformin and\u002For basal insulin\n* Have HbA1c \\> 6.5% to ≤ 11.0% at screening\n* Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \\>85th percentile\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome\n* Have had at least one episode of severe hypoglycemia and\u002For at least one episode of hypoglycemic unawareness within the last 6 months before screening\n* Have a history of pancreatitis or gallbladder disease\n* Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening\n* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening","10 Years","17 Years",{"count":199,"type":22},170,[25],"This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.\n\nParticipation in the study will last about 61 weeks.",[203],"Diabetes Mellitus, Type 2",[205,206,207,208,209,210,211,212,213],"Pediatric trial","GLP-1 receptor agonist","Oral GLP-1","Small molecule GLP-1","Youth-onset type 2 diabetes","Glycemic control","Continuous glucose monitoring","Non-inferior","Active-controlled","2026-06-22",{"date":94,"type":39},{"date":217,"type":22},"2026-09",{"date":219,"type":22},"2030-03",{"name":45,"class":46},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100610381","phase-1-a-study-of-ly4584180-in-adult-participants-with-previously-treated-blood-cancers-100610381","NCT07226843","A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers","NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a\u002F1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies","Inclusion Criteria:\n\n* Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:\n\n  * Diffuse large B-cell lymphoma - not otherwise specified\n  * High-grade B-cell lymphoma\n  * Diffuse large B-cell lymphoma - transformed from indolent lymphomas\n  * Follicular large B-cell lymphoma\n  * Follicular lymphoma\n  * Other non-Hodgkin lymphoma\n* Has measurable disease\n* Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy\n\nExclusion Criteria:\n\n* Has an active second cancer\n* Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.\n* Has known Cytomegalovirus infection. Participants with negative status are eligible\n* Has known hepatitis B or C infection or uncontrolled HIV\n* Has known significant heart disease",{"count":229,"type":22},460,[60],"The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.",[233,234,235],"Lymphoma, Non-Hodgkin's","Lymphoma, Diffuse Large B-Cell","Follicular Lymphoma",{"date":184,"type":39},{"date":238,"type":39},"2026-04-17",{"date":240,"type":22},"2030-02",{"name":45,"class":46},46,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100612842","phase-1-a-study-of-18fly4214835-in-healthy-volunteers-and-participants-with-cancer-100612842","NCT07258836","A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","A Phase 1, Open-Label Study to Evaluate the Safety, Biodistribution, Imaging Characteristics, and Radiation Dosimetry of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","Inclusion Criteria:\n\n* Cohort 1\n\n  * Have a radiologically, cytologically, or histologically confirmed diagnosis of cancer\n  * Are treatment-naïve to a systemic cancer therapy, OR have a documented disease progression on standard-of-care treatment (for example, failure of chemotherapy, targeted therapy or immunotherapy)\n  * Have at least 1 imageable tumor that is 15 millimeter (mm) or larger in the longest diameter\n* Cohort 2\n\n  * Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* Are pregnant or intend to become pregnant during their participation in the study\n* Are breastfeeding or intending to breastfeed during their participation in the study\n* Have a history of risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome)\n* Are actively receiving cancer therapy or are in between cycles of treatment\n* Have a marked baseline prolongation of QT\u002Fcorrected QT interval (QTc) interval (for example, repeated demonstration of a QTc interval greater than (\\>) 450 millisecond (ms)",{"count":251,"type":22},41,[60],"The purpose of the study is to check how safe and well-tolerated \\[18F\\]LY4214835 injection is in healthy participants and participants with cancer. The study drug will be administered intravenously (IV) (into a vein). Participation in the study will last approximately 35 days.",[255,256],"Neoplasms","Healthy",{"date":184,"type":39},{"date":259,"type":39},"2025-12-22",{"date":261,"type":22},"2027-01",{"name":45,"class":46},6,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100571496","phase-1-a-study-of-pirtobrutinib-in-participants-with-immune-thrombocytopenia-100571496","NCT06721013","A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia","A Phase 1\u002F2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia","Inclusion Criteria:\n\n* Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process\n* Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000\u002Fmicroliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy\n* Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit\n* Have a platelet count less than 30,000\u002FμL on 2 occasions at least 5 days apart in the 15 days before randomization\n* Have adequate liver, renal, and hematologic functions as defined by a table\n* Are willing to follow contraception requirements\n\nExclusion Criteria:\n\n* Have a history of any thrombotic or embolic event within 12 months before screening\n* Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization\n* Have significant cardiovascular disease\n* Have a diagnosis or history of hematologic malignancy\n* Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA)\n* Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)",{"count":272,"type":22},68,[60,137],"The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.\n\nThe study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.",[276],"Immune Thrombocytopenia (ITP)",[278],"Primary ITP",{"date":94,"type":39},{"date":281,"type":39},"2025-07-30",{"date":283,"type":22},"2029-05",{"name":45,"class":46},45,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":295,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":296,"locationsCount":297},"100257649","master-rollover-protocol-for-continued-safety-assessment-of-study-drug-100257649","NCT02632994","Master Rollover Protocol for Continued Safety Assessment of Study Drug","Inclusion Criteria:\n\n* To be eligible patients must be currently receiving benefit in a concluded Lilly study for a compound that has opened an addendum in the continued access protocol.\n\nExclusion Criteria:\n\n* Patients must not be concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.","This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and\u002For treatment.",[294],"Cancer",{"date":94,"type":39},{"name":45,"class":46},3,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},"100644108","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-overweight-or-obesity-100644108","NCT07665879","A Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity","A Phase 1, Investigator- and Participant-Blinded Study to Evaluate the Effect of Eloralintide on Insulin Sensitivity and Metabolism in Adult Participants With Overweight or Obesity","Inclusion Criteria:\n\n* Have an hemoglobin A1c (HbA1c) value at screening of less than 6.5 percent (%).\n* Have a body mass index between 25 and 45 Kilogram per Square Meter (kg\u002Fm²).\n* Have had a stable body weight that has changed by less than 5% during the 3 months prior to screening.\n* Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB). Individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP) may participate in this study.\n\nExclusion Criteria:\n\n* Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hyperosmolar state or coma. Note: Participants with a history of gestational diabetes are eligible to participate in this study.\n* Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.\n* Have a known clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal (GI) motility to a significant extent.\n* Have a prior or planned surgical treatment for obesity. Exceptions: The following are allowed if they occurred more than 1 year before screening:\n\n  * liposuction\n  * cryolipolysis, or\n  * abdominoplasty.\n* Are unwilling to comply with the lifestyle and dietary restrictions required for this study.\n* Are individuals AFAB who are lactating.\n* Are individuals AFAB who are pregnant or intend to become pregnant or to breastfeed during the study, or individuals AMAB who intend to conceive a pregnancy during the study.","70 Years",{"count":307,"type":22},115,[60],"The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.",[311,312],"Overweight","Obesity",[256],"2026-06-19",{"date":164,"type":39},{"date":317,"type":22},"2026-06",{"date":319,"type":22},"2027-08",{"name":45,"class":46},1,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"100636860","phase-1-a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosis-100636860","NCT07571174","A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period\u002Fphase as well as any off-treatment period\u002Fphase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and\u002For back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\\u003C100 GI\u002FL) is equivalent to 100,000 per cubic millimeter (100,000\u002Fmm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.",{"count":330,"type":22},32,[60],"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.",[334],"Amyotrophic Lateral Sclerosis",{"date":164,"type":39},{"date":337,"type":39},"2026-05-14",{"date":339,"type":22},"2029-06",{"name":45,"class":46},9,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":355,"leadSponsor":356,"locationsCount":341},"100636862","phase-1-a-master-protocol-olmp-a-study-of-ly4256984-in-participants-with-amyotrophic-lateral-sclerosis-als-100636862","NCT07571200","A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period\u002Fphase of the parent study as well as any off-treatment period\u002Fphase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.",{"count":330,"type":22},[60],"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.",[334],{"date":164,"type":39},{"date":337,"type":39},{"date":339,"type":22},{"name":45,"class":46},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":375},"100637375","phase-2-a-study-to-investigate-weight-management-with-macupatide-and-eloralintide-alone-or-in-combination-in-adult-participants-with-obesity-or-overweight-100637375","NCT07589608","A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight","A Phase 2b, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes","Inclusion Criteria:\n\n* See Master Protocol CWMM (NCT06143956) for inclusion criteria\n\nExclusion Criteria:\n\nIn addition to exclusion criteria in Master Protocol CWMM (NCT06143956):\n\n* Have type 1 diabetes or type 2 diabetes\n* Have an ongoing history of bradyarrhythmia and\u002For sinus bradycardia\n* Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)\n* Have a history of acute or chronic pancreatitis\n* All concomitant medications should be at a stable dose for at least 3 months prior to screening","75 Years",{"count":366,"type":22},400,[137],"The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.",[311,312],{"date":164,"type":39},{"date":372,"type":39},"2026-05-15",{"date":70,"type":22},{"name":45,"class":46},40,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":364,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},"100633925","phase-2-a-study-of-ly4005130-in-adult-participants-with-non-segmental-vitiligo-100633925","NCT07533019","A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo","A Phase 2, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Non-Segmental Vitiligo","Inclusion Criteria:\n\n* Eligible participants must have the following at both screening and baseline:\n\n  * A clinical diagnosis of non-segmented vitiligo (NSV) for at least 3 months\n  * Body surface area (BSA) involvement of 4% to 60%, inclusive, excluding involvement at palms of the hands, soles of the feet, or dorsal aspect of the feet\n  * BSA involvement of ≥0.5% on the face\n  * F-VASI ≥0.5 and T-VASI ≥3, and\n  * Either active or stable disease at both screening and baseline\n\nExclusion Criteria:\n\n* Participants who have other types of vitiligo that are not considered active or stable vitiligo\n* Currently have active forms of other disorders of pigmentation\n* Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions that would interfere with evaluation of vitiligo or response to treatment\n* Have a superficial skin infection within 2 weeks before baseline. Participants may be rescreened after the infection is resolved\n* Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year prior to screening\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking the study intervention or interfere with the interpretation of data\n* Any previous JAK inhibitor therapy, systemic or topical (for example, ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib) will NOT be allowed. Participant MUST be JAK inhibitor therapy-naïve",{"count":384,"type":22},60,[137],"The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).\n\nBlood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.\n\nThe study will last approximately 48 weeks, including screening.",[388,389],"Vitiligo","Non-Segmental Vitiligo (NSV)",{"date":184,"type":39},{"date":392,"type":39},"2026-04-14",{"date":394,"type":22},"2027-09",{"name":45,"class":46},35,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":124},"100633924","phase-2-a-study-of-ly4005130-in-adult-participants-with-severe-alopecia-areata-hair-loss-100633924","NCT07533006","A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)","A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata","Inclusion Criteria:\n\n* Have severe Alopecia Areata (AA) that meets all of the following criteria:\n\n  * Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score\n  * The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years\n  * No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months\n  * Agree not to use any AA treatments during the study\n\nExclusion Criteria:\n\n* Primarily \"diffuse\" type of AA (characterized by diffuse hair shedding)\n* Are currently experiencing other forms of alopecia\n* Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and\u002For frequent use of systemic immunosuppressants that may interfere with participation in the study\n* Have received oral JAK Inhibitors in the past\n* Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness","50 Years",{"count":384,"type":22},[137],"The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last approximately 48 weeks, including screening.",[409],"Alopecia Areata",{"date":184,"type":39},{"date":392,"type":39},{"date":413,"type":22},"2027-10",{"name":45,"class":46},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":321},"100619061","phase-1-a-study-of-ly4515100-in-healthy-participants-100619061","NCT07339722","A Study of LY4515100 in Healthy Participants","A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.\n* Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg\u002Fm\\^2) (inclusive).\n* Individuals of childbearing potential (IOCBP) are excluded from this trial.\n* Individuals not of childbearing potential (INOCBP) may participate in this trial.\n\nExclusion Criteria:\n\n* Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.\n* Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.\n* Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.\n* Participants with an estimated glomerular filtration rate \\\u003C90 mL\u002Fmin\u002F1.73 m2.\n* Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,\n* increases the risks associated with participating in the study\n* may confound ECG data analysis\n* Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing.\n* Smoke more than 10 cigarettes per day or the equivalent, including electronic cigarettes, and are unable to abide by investigative site smoking restrictions.\n* Have an average weekly alcohol intake that exceeds 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable)\n* Show evidence of\n* Human immunodeficiency virus (HIV) infection and\u002For positive human HIV antigen and\u002For antibodies\n* hepatitis C and\u002For positive hepatitis C antibody\n* hepatitis B and\u002For positive hepatitis B surface antigen.\n* Have liver disease.\n* Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment.",{"count":375,"type":22},[60],"The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 30 days and will include six overnight stays.",[256],{"date":184,"type":39},{"date":428,"type":39},"2026-01-15",{"date":68,"type":22},{"name":45,"class":46},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":364,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},"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",{"count":440,"type":22},465,[137],"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.",[444],"Opioid Use Disorder",{"date":184,"type":39},{"date":447,"type":39},"2026-02-13",{"date":449,"type":22},"2028-03",{"name":45,"class":46},57,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"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":461,"type":22},1431,[137],"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.",[465,466,467],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":184,"type":39},{"date":470,"type":39},"2026-03-26",{"date":472,"type":22},"2031-07",{"name":45,"class":46},253,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":110,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":494},"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",{"count":21,"type":22},[137],"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.",[487],"Schizophrenia",{"date":184,"type":39},{"date":490,"type":39},"2026-02-10",{"date":492,"type":22},"2027-11",{"name":45,"class":46},103,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":512,"leadSponsor":514,"locationsCount":515},"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":504,"type":22},900,[25],"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.",[311,312],[509],"Amylin receptor agonist",{"date":184,"type":39},{"date":490,"type":39},{"date":513,"type":22},"2028-07",{"name":45,"class":46},183,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":110,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":535},"100614235","phase-1-a-study-of-ly4298445-in-healthy-participants-and-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100614235","NCT07276958","A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis","Inclusion Criteria: Healthy Participants\n\nHealthy participants between the ages of 18 and 55 years.\n\n* Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg\u002Fm²), inclusive.\n\nParticipants with Systemic Lupus Erythematosus (SLE)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 6 months prior to screening.\n\nParticipants with Rheumatoid Arthritis (RA)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR\u002FEULAR classification criteria\n* Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 4.4.\n* Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies\n* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug \\[bDMARD\\] or targeted synthetic DMARD \\[tsDMARD\\]) after failing a conventional synthetic DMARD (csDMARD).\n\nExclusion Criteria:\n\n* Have known allergies to LY4298445, related compounds, or any components of the formulation\n* Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.\n* Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and\u002For by\n\n  * urine protein\u002Fcreatinine ratio greater than 200 milligrams per millimole (mg\u002Fmmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or\n  * an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL\u002Fmin)\u002F1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.\n  * requiring hemodialysis within 6 months prior to screening\n* Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening\n* Have a Class 4 RA according to the ACR revised criteria",{"count":524,"type":22},63,[60],"The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.",[256,528,529],"Systemic Lupus Erythematosus","Rheumatoid Arthritis",{"date":184,"type":39},{"date":532,"type":39},"2026-02-04",{"date":449,"type":22},{"name":45,"class":46},8,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"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":545,"type":22},800,[25],"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.",[549,312,311],"Sleep Apnea, Obstructive",{"date":184,"type":39},{"date":490,"type":39},{"date":553,"type":22},"2028-04",{"name":45,"class":46},129,""]