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)

ClinicalTrials18 Apr 2025·Phase 3● 8/10i

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)

Eli Lilly and Company

TRIUMPH-1 is a Phase 3 master protocol testing retatrutide (Eli Lilly's triple agonist) in 2,300 people with obesity or overweight without type 2 diabetes, including subsets with knee osteoarthritis and obstructive sleep apnea. The 89-week double-blind, placebo-controlled trial with optional 24-week extension measures weight change, osteoarthritis pain scores, and sleep apnea severity. Eli Lilly is positioning retatrutide across multiple obesity-related conditions beyond weight management, directly competing with Novo Nordisk's Wegovy in the obesity market. This comprehensive approach targets three distinct indications within one protocol, reflecting Lilly's strategy to establish retatrutide as a multi-indication obesity therapy.

Strategic signal

Lilly's multi-indication approach with retatrutide could challenge payers who currently cover Wegovy only for weight loss, forcing coverage decisions across osteoarthritis and sleep apnea. The knee osteoarthritis subset directly competes with traditional pain management approaches, potentially shifting rheumatology and orthopedic prescribing patterns toward metabolic therapies. This mirrors how SGLT2 inhibitors expanded from diabetes into cardiology and nephrology, creating broader reimbursement pathways and physician adoption beyond endocrinology.

Weight lossCardiovascularEli Lilly Novo Nordisk

Original Abstract

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. | Condition(s): Obesity; Overweight; Osteoarthritis, Knee; Obstructive Sleep Apnea | Primary endpoint(s): Percent Change From Baseline in Body Weight; Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset; Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset | Enrollment: 2,300 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2026-04 | Status: Active Not Recruiting | Last update: 2025-04-18

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