[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628884":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":37,"studyPopulation":11,"armGroups":38,"interventions":64,"overallOfficials":11,"centralContacts":78,"locations":84,"responsibleParty":104,"collaborators":11,"id":106,"slug":11,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":11,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":87,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Mean percent change in body weight from randomization\u002Fbaseline to Week 24.",null,"24 weeks",[14,17,19,21,23,25],{"measure":15,"description":11,"timeFrame":16},"Mean percent change in body weight from baseline to Week 48","48 weeks",{"measure":18,"description":11,"timeFrame":16},"Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48.",{"measure":20,"description":11,"timeFrame":16},"Mean change in body weight (kg) at Weeks 24 and 48.",{"measure":22,"description":11,"timeFrame":16},"Mean change in BMI (kg\u002Fm²) at Weeks 24 and 48.",{"measure":24,"description":11,"timeFrame":16},"Mean change in waist circumference (cm) at Weeks 24 and 48",{"measure":26,"description":11,"timeFrame":16},"Safety and tolerability outcomes (e.g., treatment-emergent adverse events; serious adverse events; discontinuations due to adverse events).",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"RANDOMIZED","PARALLEL","Participants randomized to once-weekly subcutaneous retatrutide dose regimens (with dose escalation for selected arms) or placebo for 48 weeks, with standardized lifestyle counseling throughout.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"SINGLE","To preserve blinding, placebo participants follow an injection dose-escalation schedule matched to one of the active retatrutide arms.",[36],"PARTICIPANT","After screening (up to 6 weeks), eligible participants are randomized to one of several dose-escalation regimens leading to maintenance doses of 1, 4, 8, or 12 mg retatrutide (or placebo) administered once weekly for 48 weeks, followed by a 4-week safety follow-up. Two maintenance dose levels (4 mg and 8 mg) include alternative escalation schedules to evaluate tolerability. The primary efficacy evaluation is at Week 24 (percent change in body weight), with additional weight, anthropometric, and safety assessments through Week 48.",[39,46,49,52,55,58,61],{"label":40,"type":41,"description":11,"interventionNames":42},"Retatrutide (LY3437943) 1 mg once weekly (no escalation)","EXPERIMENTAL",[43,44,45],"Drug: Retatrutide (LY3437943)","Drug: Placebo","Behavioral: Standardized diet and physical activity counseling throughout the study.",{"label":47,"type":41,"description":11,"interventionNames":48},"Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg.",[43,44,45],{"label":50,"type":41,"description":11,"interventionNames":51},"Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation).",[43,44,45],{"label":53,"type":41,"description":11,"interventionNames":54},"Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg",[43,44,45],{"label":56,"type":41,"description":11,"interventionNames":57},"Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg.",[43,44,45],{"label":59,"type":41,"description":11,"interventionNames":60},"Placebo once weekly (matched escalation schedule to maintain blinding).",[43,44,45],{"label":62,"type":41,"description":11,"interventionNames":63},"Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.",[43,44,45],[65,70,74],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"DRUG","Retatrutide (LY3437943)","subcutaneous injection, once weekly (dose per assigned arm).",[59,40,56,47,50,53,62],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"Placebo","subcutaneous injection, once weekly (schedule matched to an active arm).",[59,40,56,47,50,53,62],{"type":75,"name":76,"description":76,"armGroupLabels":77,"otherNames":11},"BEHAVIORAL","Standardized diet and physical activity counseling throughout the study.",[59,40,56,47,50,53,62],[79],{"name":80,"role":81,"phone":82,"phoneExt":11,"email":83},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":94,"coordinates":95},"Point",[96,97],114.0683,22.54554,{"lat":97,"lon":96},[100],{"name":101,"role":81,"phone":102,"phoneExt":11,"email":103},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":105,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":117,"type":118},300,"ESTIMATED","INTERVENTIONAL",[121],"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.",[124],"Obesity",[126,127,128,129,130,131,132,133,134,135,136],"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":139,"type":140},"2026-03-12","ACTUAL",{"date":142,"type":140},"2026-02-15",{"date":144,"type":118},"2028-02-17",{"name":5,"class":6},1]