[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07476118":3,"trial-entities:NCT07476118":123,"trial-summary:NCT07476118":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":45,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":87,"locations":90,"central_contacts":116,"overall_officials":117,"references":121,"see_also_links":122},"NCT07476118","27802","A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity","A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity","ACTIVE_NOT_RECRUITING","2027-02","2026-07","2026-07-16","2026-03-18","Eli Lilly and Company","INDUSTRY",false,"The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.",null,[19,20],"Obesity","Overweight",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE1",{"count":27,"type":28},150,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Brenipatide","Administered SC.",[32],[36],"LY3537031",{"type":38,"name":39,"description":33,"armGroupLabels":40},"OTHER","Placebo",[39],[42],{"measure":43,"timeFrame":44},"Percent Change in Body Weight","Week 1, Week 29",[46,49,51,54,56,59,61,63,65,67],{"measure":47,"timeFrame":48},"Number of Participants who discontinued due to an Adverse Events (AEs)","Day 1 through Week 37",{"measure":50,"timeFrame":48},"Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs",{"measure":52,"timeFrame":53},"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide","Pre-dose on Day 1 through Week 37",{"measure":55,"timeFrame":53},"PK: Maximum Concentration (Cmax) of Brenipatide",{"measure":57,"timeFrame":58},"Percentage of Participants Achieving ≥ 5% Reduction in Body Weight","Week 29",{"measure":60,"timeFrame":44},"Change in Waist Circumference",{"measure":62,"timeFrame":44},"Change in Waist-to-Height Ratio",{"measure":64,"timeFrame":44},"Change in Blood Pressure",{"measure":66,"timeFrame":44},"Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)",{"measure":68,"timeFrame":44},"Change in High-sensitive C-reactive Protein (hsCRP)","ALL","18 Years","65 Years",true,{"inclusion":74,"exclusion":78,"raw_text":86},[75,76,77],"Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation","Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg\u002Fm\\^2)","Have no significant (not more than 5 percent \\[%\\]) self-reported weight gain or loss in the past 3 months prior to screening",[79,80,81,82,83,84,85],"Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data","Have a prior diagnosis of type 1 or type 2 diabetes mellitus","Have a history of acute or chronic pancreatitis","Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2","Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor agonist, GIP\u002FGLP-1\u002Fglucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening","Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal\u002Fnutritional supplements), that promote weight loss within 6 months prior to screening","Are pregnant or lactating","Inclusion Criteria:\n\n* Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation\n* Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg\u002Fm\\^2)\n* Have no significant (not more than 5 percent \\[%\\]) self-reported weight gain or loss in the past 3 months prior to screening\n\nExclusion Criteria:\n\n* Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data\n* Have a prior diagnosis of type 1 or type 2 diabetes mellitus\n* Have a history of acute or chronic pancreatitis\n* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2\n* Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor agonist, GIP\u002FGLP-1\u002Fglucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening\n* Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal\u002Fnutritional supplements), that promote weight loss within 6 months prior to screening\n* Are pregnant or lactating",[88,89],"ADULT","OLDER_ADULT",[91,100,108],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"Fortrea Clinical Research Unit - Daytona Beach","Daytona Beach","Florida","32117-5116","United States",{"lat":98,"lon":99},29.21081,-81.02283,{"facility":101,"city":102,"state":103,"zip":104,"country":96,"geoPoint":105},"Fortrea Clinical Research Unit","Dallas","Texas","75247",{"lat":106,"lon":107},32.78306,-96.80667,{"facility":109,"city":110,"state":111,"zip":112,"country":96,"geoPoint":113},"Fortrea Clinical Research Unit Inc. - Madison","Madison","Wisconsin","53704",{"lat":114,"lon":115},43.07305,-89.40123,[],[118],{"name":119,"affiliation":13,"role":120},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":124,"biomarkers":125},[19,20],[],{"nct_id":4,"found":72,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study involving about 150 participants. Some participants will receive brenipatide, and others will receive a placebo (an inactive substance).","completed","A Study of Brenipatide for Overweight or Obesity","This study is testing a drug called brenipatide (LY3537031) in healthy people who are overweight or have obesity. Researchers want to see how different doses of brenipatide, given as shots under the skin, work and how safe they are. You might be able to join if you are between 18 and 65 years old, have a body mass index (BMI) between 27.0 and 45.0, and haven't had a big weight change recently. The main way they will measure success is by looking at the percentage of body weight change at Week 1 and Week 29. This study is looking for about 150 participants, but its current status is unclear.","The primary outcome of body weight change will be measured at Week 1 and Week 29.",109,"Participation in this study will last about 42 weeks. You will receive subcutaneous (under the skin) injections.","Not stated in the trial record.",[32],"v2"]