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OpenTrials
Completed

NCT Number: NCT05882045

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundación Respirar, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 80

Secondary outcomes

  1. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 80

  3. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 80

  4. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 80

  5. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 80

  6. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 80

  7. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 80

  8. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 80

  9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score

    Time frame: Baseline, Week 80

  10. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: TRIUMPH-3

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 31, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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