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Trial · Interventional

CompletedPhase 3Registry data

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

Short name TRIUMPH-3

NCTNCT05882045 (opens ClinicalTrials.gov in a new tab)Other id18582Other idJ1I-MC-GZBMOther id2023-503659-88-00Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,946 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
10 countries

United States, Argentina, Australia, Canada, Hungary, Mexico, Poland, Puerto Rico, Slovakia, Spain

Start
30 May 2023
Primary completion
16 Apr 2026
Completion
14 May 2026
First posted
31 May 2023
Last update posted
30 Jul 2026
Conditions
Obesity · Cardiovascular Diseases

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 3

    TRIUMPH-3

    NCT05882045

    30 May 2023 to 14 May 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • RetatrutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Retatrutide Dose 1

    Participants will receive retatrutide subcutaneously (SC).

  • Experimental

    Retatrutide Dose 2

    Participants will receive retatrutide SC.

  • Placebo comparator

    Placebo

    Participants will receive placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 80

Secondary outcomes(10)

  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

    Registry description

    AUC is presented as a single average measure of AUC across the study duration.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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