A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

Clinical Trial22 May 2026Phase 3

A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

Eli Lilly and Company

Phase 3 randomized, double-blind, placebo-controlled study evaluates retatrutide once weekly in people with severe obesity and established cardiovascular disease. The trial targets 1,800 participants over 113 weeks, with primary endpoint of percent change in body weight from baseline. Eli Lilly is advancing retatrutide, a triple agonist (GLP-1/GIP/glucagon), into a high-risk cardiovascular population that represents a significant commercial opportunity beyond standard obesity treatment. This positions retatrutide as a potential competitor to Wegovy, which gained cardiovascular risk reduction approval in March 2024 for people with obesity and established CVD.

Strategic Signal

Eli Lilly is directly challenging Novo Nordisk's cardiovascular positioning with Wegovy by testing retatrutide in the same high-value population of people with obesity and established CVD. This head-to-head competitive dynamic will likely intensify cardiovascular outcomes messaging and could fragment the premium-priced obesity market where Wegovy currently holds the cardiovascular risk reduction claim. US payers and cardiology societies will watch closely, as cardiovascular outcomes data historically drives formulary preference and specialist adoption in this population.

Weight lossCardiovascularGLP-1Eli Lilly

Original Abstract

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks. | Condition(s): Obesity; Cardiovascular Diseases | Primary endpoint(s): Percent Change from Baseline in Body Weight | Enrollment: 1,946 (actual) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2026-04-16 | Status: Active Not Recruiting | Last update: 2026-05-22

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