Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHudson Biotech
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Retatrutide (LY3437943)
- Placebo
- Standardized diet and physical activity counseling throughout the study.
Treatment groups
300 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov