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TRIUMPH-3

Active not recruitingPhase 3

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

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

169

Recruiting sites

Enrollment

1,946

actual

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criteria

BMI ≥35Established CVD

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05882045
Org study ID18582
Secondary ID2023-503659-88-00EU Trial Number
Secondary IDJ1I-MC-GZBMEli Lilly and Company

Timeline

Milestones

Study start2023-05-30actual
Study first posted2023-05-31actual
Primary completion2026-04-16actual
Last update posted2026-05-22actual
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
4
Weight & body composition
3
Glycemic / diabetes
2
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 80

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 80

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 80

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 80

percent change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 80

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 80

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 80

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 80

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

SF-36 physical

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)

Time frame:Baseline to Week 80

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.