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Retatrutide-Obesity
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
What is the rationale for the placebo‑controlled design of the TRIUMPH‑Outcomes retatrutide trial?
TRIUMPH-Outcomes is a phase 3, placebo-controlled, event-driven trial of retatrutide in adults with BMI ≥27 and ASCVD and/or CKD, assessing CV and renal outcomes; at design, no incretin therapies were approved for these indications in this population.
Content Overview
Why Is TRIUMPH-Outcomes a Placebo-Controlled Trial Instead of an Active-Comparator Trial?
When the TRIUMPH-Outcomes trial was designed, no incretin-based therapies were approved by regulatory agencies to reduce cardiovascular risk or prevent the worsening of kidney function in patients with overweight or obesity and established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Per study protocol, investigators were encouraged to optimize participants' standard of care therapies for CV risk management and/or CKD during the trial, in accordance with local treatment guidelines.1
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What is the Retatrutide TRIUMPH-Outcomes Clinical Trial Design?
TRIUMPH-Outcomes is a phase 3, randomized, double-blind, placebo-controlled, event-driven study. The main purpose of this study is to determine if retatrutide can significantly
- lower the incidence of serious CV complications, or
- prevent the worsening of kidney function.2
The trial includes adults with body mass index (BMI) ≥27 kg/m2 and ASCVD and/or CKD.2
Participants are randomized to receive either retatrutide or placebo, administered subcutaneously (SC), with retatrutide doses escalated to a maximum tolerated dose. The study will last for about 5 years.2
What Are the TRIUMPH-Outcomes Inclusion and Exclusion Criteria?
TRIUMPH-Outcomes Clinical Trial Participation Criteria presents the TRIUMPH-Outcomes participant criteria.
Inclusion Criteria |
Exclusion Criteria |
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Abbreviations: ASCVD = atherosclerotic cardiovascular disease; BMI = body mass index; CKD = chronic kidney disease; CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; MEN = multiple endocrine neoplasia; NYHA = New York Heart Association; T2D = type 2 diabetes; UACR = urine albumin-creatinine ratio.
aeGFR is calculated by central lab based on CKD-EPI creatinine-cystatin c equation as determined by central lab.
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What Are the Key Primary and Secondary Endpoints in the TRIUMPH-Outcomes Trial?
TRIUMPH-Outcomes Primary and Secondary Endpoints presents the trial endpoints.
Primary Outcome Measuresa |
Time to first occurrence of composite endpoints Composite endpoint includes
|
Time to first occurrence of composite endpoint of |
Secondary Outcome Measuresa |
Time to first occurrence of composite endpoint of MACE-3, which includes
|
Time to first occurrence of composite endpoint of CV death or hospitalization/urgent visit due to HF |
Time to occurrence of all-cause death |
Time to first occurrence of composite endpoint of ≥40% sustained decline in eGFR, ESRD, or renal death |
Percentage change from baseline albuminuria (UACR) in participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline. |
Abbreviations: CV = cardiovascular; eGFR = estimated glomerular filtration rate; ESKD = end-stage kidney disease; ESRD = end-stage renal disease; HF = heart failure; MACE = major adverse cardiovascular event; MI = myocardial infarction; UACR = urine albumin-creatinine ratio.
aTimeframe is from randomization to study completion (approximate 248 weeks).
bConfirmed by 2 measurements at least 4 weeks apart at the central laboratory.
cConfirmed by a repeated measure at least 4 weeks after the first result.
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Reference
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2The effect of retatrutide once weekly on cardiovascular outcomes and kidney outcomes in adults living with obesity (TRIUMPH-Outcomes). Clinicaltrials.gov identifier: NCT06383390. Updated January 21, 2026. Accessed February 5, 2026. https://clinicaltrials.gov/study/NCT06383390
Date of Last Review: February 03, 2026