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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hudson Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-03-14
• Completion: 2028-02-17
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: China