DRUG
Retatrutide
Administered SC
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Status
Completed
Phase
Phase 3
Enrollment
1,946
Locations
169
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Administered SC
Timeline
From registration to results.
First posted
May 31, 2023
Study start
May 30, 2023
Primary completion
Apr 16, 2026
Study completion
May 14, 2026
Results posted
Not reported
Registry updated
Jul 30, 2026
Outcomes
What the study measures.
Primary outcomes
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 80
Secondary outcomes
Change from Baseline in Body Mass Index (BMI)
Time frame · Baseline, Week 80
Change from Baseline in Waist Circumference
Time frame · Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Time frame · Baseline, Week 80
Percent Change from Baseline in Triglycerides
Time frame · Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame · Baseline, Week 80
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 80
Percent Change from Baseline in Fasting Insulin
Time frame · Baseline, Week 80
Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
Time frame · Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
Time frame · Baseline to Week 80
AUC is presented as a single average measure of AUC across the study duration.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
169 registered sites.
Argentina · Australia · Canada · Hungary · Mexico · Poland · Puerto Rico · Slovakia · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Humphreys Diabetes Center
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States
Brengle Family Medicine
Indianapolis, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Retatrutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Eli Lilly · Type 2 Diabetes · Obesity
Phase 3
Completed
1,152
2026-07
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Eli Lilly · Obesity · Overweight
Phase 3
Active, not recruiting
586
2026-07
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Eli Lilly · Type 2 Diabetes
Phase 3
Active, not recruiting
320
2026-07
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Eli Lilly · Atherosclerotic Cardiovascular Disease (ASCVD) · Chronic Kidney Disease (CKD)
Phase 3
Active, not recruiting
10,000
2026-07
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
Eli Lilly · Obesity
Phase 3
Active, not recruiting
800
2026-07
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Eli Lilly · Metabolic Dysfunction-Associated Steatotic Liver Disease
Phase 3
Recruiting
4,500
2026-07
A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
Eli Lilly · Diabetes Mellitus · Insulin Sensitivity
Phase 1
Active, not recruiting
95
2026-07
A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
Eli Lilly · Type 2 Diabetes Mellitus
Phase 1
Completed
80
2026-06
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.