A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 300 participants

Interventions

• DRUG: Retatrutide (LY3437943) — subcutaneous injection, once weekly (dose per assigned arm).
• DRUG: Placebo — subcutaneous injection, once weekly (schedule matched to an active arm).
• BEHAVIORAL: Standardized diet and physical activity counseling throughout the study. — Standardized diet and physical activity counseling throughout the study.

Primary Outcomes

• Mean percent change in body weight from randomization/baseline to Week 24. (24 weeks)

Secondary Outcomes

• Mean percent change in body weight from baseline to Week 48 (48 weeks)
• Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48. (48 weeks)
• Mean change in body weight (kg) at Weeks 24 and 48. (48 weeks)
• Mean change in BMI (kg/m²) at Weeks 24 and 48. (48 weeks)
• Mean change in waist circumference (cm) at Weeks 24 and 48 (48 weeks)

Trial Locations

• Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

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