[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628884":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":11,"centralContacts":48,"locations":54,"responsibleParty":74,"collaborators":11,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",[8,16,19,22,25,28,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Retatrutide (LY3437943) 1 mg once weekly (no escalation)","EXPERIMENTAL",null,[13,14,15],"Drug: Retatrutide (LY3437943)","Drug: Placebo","Behavioral: Standardized diet and physical activity counseling throughout the study.",{"label":17,"type":10,"description":11,"interventionNames":18},"Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg.",[13,14,15],{"label":20,"type":10,"description":11,"interventionNames":21},"Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation).",[13,14,15],{"label":23,"type":10,"description":11,"interventionNames":24},"Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg",[13,14,15],{"label":26,"type":10,"description":11,"interventionNames":27},"Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg.",[13,14,15],{"label":29,"type":10,"description":11,"interventionNames":30},"Placebo once weekly (matched escalation schedule to maintain blinding).",[13,14,15],{"label":32,"type":10,"description":11,"interventionNames":33},"Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.",[13,14,15],[35,40,44],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","Retatrutide (LY3437943)","subcutaneous injection, once weekly (dose per assigned arm).",[29,9,26,17,20,23,32],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Placebo","subcutaneous injection, once weekly (schedule matched to an active arm).",[29,9,26,17,20,23,32],{"type":45,"name":46,"description":46,"armGroupLabels":47,"otherNames":11},"BEHAVIORAL","Standardized diet and physical activity counseling throughout the study.",[29,9,26,17,20,23,32],[49],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":64,"coordinates":65},"Point",[66,67],114.0683,22.54554,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":11,"email":73},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":75,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100628884","phase-2-effect-of-ly3437943-versus-placebo-in-participants-who-have-obesity-or-are-overweight-100628884",false,"NCT07467447","Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight","A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities","GZBF","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive) at time of informed consent.\n* BMI ≥30 and ≤50 kg\u002Fm², OR BMI ≥27 and \\\u003C30 kg\u002Fm² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).\n* Motivated and able\u002Fwilling to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.\n* Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).\n* Male and\u002For female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding.\n* Capable of giving signed informed consent and complying with protocol requirements.\n\nExclusion Criteria:\n\n* History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state\u002Fcoma.\n* Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg\u002FdL; or random glucose ≥200 mg\u002FdL).\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening.\n* Prior or planned surgical treatment for obesity (exceptions: liposuction\u002Fabdominoplasty \\>1 year prior).\n* Current\u002Fplanned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization).\n* Renal impairment: eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m² (CKD-EPI) at screening.\n* Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility.\n* History of acute or chronic pancreatitis (exception for resolved gallstone pancreatitis post-cholecystectomy).\n* TSH outside 0.4 to 6.0 mIU\u002FL at screening (with protocol-defined exceptions).\n* Obesity due to other endocrine disorders (e.g., Cushing's) or monogenic\u002Fsyndromic obesity (e.g., Prader-Willi).\n* Psychiatric exclusion criteria including unstable major depressive disorder\u002Fsevere psychiatric disorder within 2 years; lifetime suicide attempt; PHQ-9 score ≥15; or specified Columbia-Suicide Severity Rating Scale (C-SSRS) findings within past month.\n* Uncontrolled hypertension (systolic ≥160 mmHg and\u002For diastolic ≥100 mmHg) or elevated resting pulse rate (\\>100 bpm) at baseline.\n* Recent (within 3 months) major cardiovascular events (e.g., MI, stroke, unstable angina, CHF hospitalization); tachyarrhythmia syndromes; NYHA Class III-IV CHF; or ECG abnormalities interfering with interpretation.\n* Acute\u002Fchronic hepatitis or liver disease other than NAFLD; or screening labs: ALT \\>3× ULN, ALP \\>1.5× ULN, or total bilirubin \\>1.5× ULN (with exception).\n* Elevated calcitonin at Visit 1 per protocol thresholds; personal\u002Ffamily history of medullary thyroid carcinoma or MEN2.\n* Active\u002Funtreated malignancy or remission \\\u003C5 years (with protocol exceptions for certain in-situ\u002Fskin cancers).\n* Contraindication to GLP-1 receptor agonists, or other conditions that could prevent protocol compliance (including drug\u002Falcohol abuse or eating disorder), per investigator judgment.\n* Alcohol consumption \\>14 units\u002Fweek (women) or \\>21 units\u002Fweek (men).\n* Recent marijuana\u002FTHC-containing product use within 3 months or unwillingness to abstain during trial (protocol exception for cannabidiol oil if agrees to refrain).\n* Organ transplant history (except corneal transplant) or awaiting transplant.\n* Hematologic conditions interfering with HbA1c measurement; recent large blood donation\u002Ftransfusion\u002Fsevere blood loss; hemoglobin below protocol thresholds.\n* Severe atopy\u002Fmultiple severe allergies or severe hypersensitivity reactions.\n* Fasting triglycerides \\>500 mg\u002FdL at screening (with stability requirement for lipid-lowering therapy).\n* Significant active, uncontrolled medical condition or history posing risk or interfering with data interpretation, per investigator judgment.\n* History of symptomatic gallbladder disease within past 2 years (protocol-defined exceptions after cholecystectomy).\n* History of documented HIV infection.\n* Chronic systemic glucocorticoid therapy within 3 months or active autoimmune abnormality likely to require systemic steroids during study (with specified formulation exceptions).\n* Recent medications that may cause significant weight gain (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers) within 3 months.\n* Recent use (within 3 months) of medications or remedies intended to promote weight loss (examples listed in protocol, including GLP-1 RAs).\n* Use of metformin or other glucose-lowering medications (e.g., for PCOS or diabetes prevention) not permitted at entry.\n* Started implantable\u002Finjectable contraceptives within 18 months prior to screening (IUDs allowed if used ≥3 months).\n* Known allergies to GLP-1 receptor agonists or LY3437943.\n* Currently enrolled in another investigational study or recent participation\u002Ftreatment within 30 days (or 5 half-lives, whichever longer).\n* Previously received LY3437943 in this or another study.\n* Investigator site personnel directly affiliated with the study and\u002For their immediate family; or Lilly employees.\n* Note: The publicly posted protocol references additional exclusion criteria numbered 52-57 in a separate protocol addendum (not included in the posted protocol PDF).","ALL","18 Years","75 Years",{"count":88,"type":89},300,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.",[95],"Obesity",[97,98,99,100,101,102,103,104,105,106,107],"Retatrutide","LY3437943","triple agonist","GIP receptor agonist","GLP-1 receptor agonist","glucagon receptor agonist","weight loss","body weight","BMI","waist circumference","lifestyle counseling","2026-03-08",{"date":110,"type":111},"2026-03-12","ACTUAL",{"date":113,"type":111},"2026-02-15",{"date":115,"type":89},"2028-02-17",{"name":5,"class":6},1]