NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,300 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Conditions

• Obesity
• Overweight
• Osteoarthritis, Knee
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Retatrutide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2023-07-10
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2023-07-03
• Last updated: 2025-04-18

Locations

134 sites across 12 countries: United States, Australia, Brazil, Canada, Hungary, India, Mexico, Poland, Puerto Rico, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study