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TRIUMPH-5

Active not recruitingPhase 3

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity

Assets

Retatrutide / Tirzepatide

Listed sites

65

Recruiting sites

Enrollment

800

estimated

Study population

Obesity / overweight

Key I/E criterion

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 IDNCT06662383
Org study ID18585
Secondary ID2024-511450-49-00
Secondary IDJ1I-MC-GZBPEli Lilly and Company

Timeline

Milestones

Study first posted2024-10-28actual
Study start2024-11-01actual
Last update posted2026-04-13actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.

Exclusion criteria

Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening.
Have a prior or planned surgical treatment for obesity.
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
Have had within the past 90 days before screening:
acute myocardial infarction
cerebrovascular accident (stroke)
coronary revascularization
hospitalization for unstable angina, or
hospitalization due to congestive heart failure.
Have New York Heart Association Functional Classification Class IV congestive heart failure.
Have a history of chronic or acute pancreatitis.

Endpoints (10)

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

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 Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

Time frame:Baseline, Week 80

IWQOL-Lite total

change from baseline, improvement

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.