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)

Clinical Trial3 Jun 2026Phase 3

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: 2,335 (actual) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2026-04-06 | Status: Completed | Last update: 2026-06-03

View original source ↗

Related signals

Strategic Signal

FDA1 Apr 2026New Drug Approval (NDA/BLA)High impact● 10/10i

FDA Approves Foundayo (Orforglipron) — New Drug Approval (NDA/BLA)

FDA approved orforglipron (Foundayo, Eli Lilly) for type 2 diabetes -- a once-daily oral small-molecule GLP-1 receptor agonist. Orforglipron is the first non-peptide oral GLP-1 approved in the US; oral semaglutide (Rybelsus, Novo Nordisk) has been approved for T2D since 2019 and expanded to obesity in January 2026. Unlike Rybelsus, orforglipron requires no fasting or water volume restrictions before dosing.

GLP-1Type 2 diabetesPricing/accessEli Lilly Novo Nordisk

Strategic Signal

Clinical Trial19 Mar 2026Phase 3High impact● 9/10i

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Phase 3 SURMOUNT-1 tests once-weekly tirzepatide at three doses versus placebo in adults without type 2 diabetes who have obesity or are overweight with comorbidities. The randomized, double-blind trial targets 2,539 participants with primary efficacy assessment at 72 weeks. This represents tirzepatide's pivotal obesity trial against placebo, potentially supporting Eli Lilly's bid to compete directly with Wegovy in the non-diabetic obesity market. A prediabetes subgroup continues long-term to assess diabetes prevention.

Weight lossGLP-1Eli Lilly

Strategic Signal

FDA19 Mar 2026Supplemental Approval: Efficacy [Priority Review]High impact● 9/10i

FDA Approves Imcivree (Setmelanotide): Supplemental Approval: Efficacy [Priority Review]

FDA approved a supplemental application for Imcivree (setmelanotide, Rhythm) on March 19, 2026, under priority review. This represents an efficacy-based label expansion for the melanocortin-4 receptor agonist, which was initially approved for rare genetic obesity disorders. Rhythm gains additional indication breadth in the specialized rare obesity market, where treatment options remain extremely limited. The priority review designation signals FDA recognition of significant unmet medical need in the expanded patient population.

Weight lossOtherRhythm

Strategic Signal

Clinical Trial17 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Phase 3 open-label trial compared once-daily oral orforglipron versus insulin glargine in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study enrolled 2,749 participants with primary endpoint of time to first major adverse cardiovascular event, completed in March 2026. Eli Lilly is positioning orforglipron as a cardiovascular outcomes option in high-risk populations, directly competing with established insulin therapy in this indication. This represents the first cardiovascular outcomes trial for orforglipron following its April 2026 FDA approval for type 2 diabetes.

GLP-1Type 2 diabetesWeight lossCardiovascularEli Lilly