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

Short name TRIUMPH-5

NCTNCT06662383Other id18585Other idJ1I-MC-GZBPOther id2024-511450-49-00

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 800 participants (estimated)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 5 countries
United States, Argentina, Germany, Poland, Puerto Rico
Start: 1 Nov 2024
Primary completion: Nov 2026 (estimated)
Completion: Dec 2026 (estimated)
First posted: 28 Oct 2024
Last update posted: 20 Jul 2026
Conditions: Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 3
TRIUMPH-5
NCT06662383
1 Nov 2024 to est. Dec 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 compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

Interventions

RetatrutideDrug
TirzepatideDrug

Arms2

Experimental
Retatrutide
Participants will receive retatrutide administered subcutaneously (SC)
Active comparator
Tirzepatide
Participants will receive tirzepatide administered SC

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 80

Secondary outcomes(9)

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 Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Time frame · Baseline, Week 80

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.

A trial that is still running, or that stopped early, may post results later.

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 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.

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