> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/effect-of-ly3437943-versus-placebo-in-participants-who-have-dcbc17b3-239a-4f7a-989d-6121a937471a > Record changed: 2026-10-13 # Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight NCT07467447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Lead sponsor Hudson Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Start date 2026-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Acronym** GZBF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Short title** Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Official title** A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Dates **Completion date** 2028-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **First posted** 2026-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Registry last updated** 2026-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Primary completion date** 2027-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Start date** 2026-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Lead sponsor** Hudson Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Identifiers **Registry ID** NCT07467447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **ClinicalTrials.gov ID** NCT07467447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masking description** To preserve blinding, placebo participants follow an injection dose-escalation schedule matched to one of the active retatrutide arms. **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Outcomes ### Primary outcomes 1. Mean percent change in body weight from randomization/baseline to Week 24. Timeframe: 24 weeks ### Secondary outcomes 1. Mean percent change in body weight from baseline to Week 48 Timeframe: 48 weeks 2. Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48. Timeframe: 48 weeks 3. Mean change in body weight (kg) at Weeks 24 and 48. Timeframe: 48 weeks 4. Mean change in BMI (kg/m²) at Weeks 24 and 48. Timeframe: 48 weeks 5. Mean change in waist circumference (cm) at Weeks 24 and 48 Timeframe: 48 weeks 6. Safety and tolerability outcomes (e.g., treatment-emergent adverse events; serious adverse events; discontinuations due to adverse events). Timeframe: 48 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Age 18 to 75 years (inclusive) at time of informed consent. - BMI ≥30 and ≤50 kg/m², OR BMI ≥27 and <30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure). - Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires. - Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum). - Male and/or female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding. - Capable of giving signed informed consent and complying with protocol requirements. ### Exclusion criteria - History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma. - Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL). - Self-reported change in body weight >5 kg within 3 months prior to screening. - Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty >1 year prior). - Current/planned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization). - Renal impairment: eGFR <45 mL/min/1.73 m² (CKD-EPI) at screening. - Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility. - History of acute or chronic pancreatitis (exception for resolved gallstone pancreatitis post-cholecystectomy). - TSH outside 0.4 to 6.0 mIU/L at screening (with protocol-defined exceptions). - Obesity due to other endocrine disorders (e.g., Cushing's) or monogenic/syndromic obesity (e.g., Prader-Willi). - Psychiatric exclusion criteria including unstable major depressive disorder/severe 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. - Uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg) or elevated resting pulse rate (>100 bpm) at baseline. - 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. - Acute/chronic 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). - Elevated calcitonin at Visit 1 per protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2. - Active/untreated malignancy or remission <5 years (with protocol exceptions for certain in-situ/skin cancers). - Contraindication to GLP-1 receptor agonists, or other conditions that could prevent protocol compliance (including drug/alcohol abuse or eating disorder), per investigator judgment. - Alcohol consumption >14 units/week (women) or >21 units/week (men). - Recent marijuana/THC-containing product use within 3 months or unwillingness to abstain during trial (protocol exception for cannabidiol oil if agrees to refrain). - Organ transplant history (except corneal transplant) or awaiting transplant. - Hematologic conditions interfering with HbA1c measurement; recent large blood donation/transfusion/severe blood loss; hemoglobin below protocol thresholds. - Severe atopy/multiple severe allergies or severe hypersensitivity reactions. - Fasting triglycerides >500 mg/dL at screening (with stability requirement for lipid-lowering therapy). - Significant active, uncontrolled medical condition or history posing risk or interfering with data interpretation, per investigator judgment. - History of symptomatic gallbladder disease within past 2 years (protocol-defined exceptions after cholecystectomy). - History of documented HIV infection. - Chronic systemic glucocorticoid therapy within 3 months or active autoimmune abnormality likely to require systemic steroids during study (with specified formulation exceptions). - Recent medications that may cause significant weight gain (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers) within 3 months. - Recent use (within 3 months) of medications or remedies intended to promote weight loss (examples listed in protocol, including GLP-1 RAs). - Use of metformin or other glucose-lowering medications (e.g., for PCOS or diabetes prevention) not permitted at entry. - Started implantable/injectable contraceptives within 18 months prior to screening (IUDs allowed if used ≥3 months). - Known allergies to GLP-1 receptor agonists or LY3437943. - Currently enrolled in another investigational study or recent participation/treatment within 30 days (or 5 half-lives, whichever longer). - Previously received LY3437943 in this or another study. - Investigator site personnel directly affiliated with the study and/or their immediate family; or Lilly employees. - Note: The publicly posted protocol references additional exclusion criteria numbered 52-57 in a separate protocol addendum (not included in the posted protocol PDF). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Sites - Peking University Shenzhen HospitalShenzhen, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07467447) ## Related records ### Drugs (1) - [Retatrutide](https://trialight.com/data/asset/retatrutide-1c18d390-804a-469b-95a1-d654ddcca41e.md) ### Lead sponsors (1) - [Hudson Biotech](https://trialight.com/data/company/hudson-biotech-5ca21cf4-ffd1-4e39-ab8d-7abfb382958e.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (3) - [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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