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ACTIVE_NOT_RECRUITINGPHASE3

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

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

NCT05882045•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
•Have established cardiovascular (CV) disease with at least 1 of the following:
•* prior myocardial infarction
•* prior ischemic or hemorrhagic stroke, or
•* symptomatic peripheral arterial disease
•Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria

•Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
•Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
•Have a prior or planned surgical treatment of obesity.
•Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
•Have Type 1 diabetes.
•Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
•Have had pancreatitis.

Locations (169)

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Valley Clinical Trials, Inc.

Covina, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Valley Research

Fresno, California, United States

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Velocity Clinical Research, Panorama City

Van Nuys, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Key Dates

Start Date

May 30, 2023

Primary Completion Date

April 1, 2026

Completion Date

May 1, 2026

Last Updated

July 23, 2025

Enrollment

1,800

ESTIMATED participants

Conditions

ObesityCardiovascular Diseases

Interventions

Retatrutide

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Inclusion Criteria

Exclusion Criteria

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