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Trial · Interventional

Active, not recruitingPhase 3Registry data

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

NCTNCT06383390 (opens ClinicalTrials.gov in a new tab)Other id18584Other idJ1I-MC-GZBOOther id2023-508630-34-00Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
10,000 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
27 countries

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Start
30 Apr 2024
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
First posted
25 Apr 2024
Last update posted
8 Oct 2026
Conditions
Atherosclerotic Cardiovascular Disease (ASCVD) · Chronic Kidney Disease (CKD)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027202820292030
  1. Ph 3

    The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

    NCT06383390

    30 Apr 2024 to est. Feb 2029

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 determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Retatrutide

    Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.

  • Placebo comparator

    Placebo

    Participants will receive matching placebo administered SC.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to First Occurrence of Composite Endpoints

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

    Registry description

    A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).

  2. Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

    Registry description

    ESKD is defined as the following individual components: persistent eGFR \<15 mL/min/1.73 m\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.

Secondary outcomes(5)

  1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

    Registry description

    MACE-3 includes CV death, nonfatal MI, and nonfatal stroke.

  2. Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

    Registry description

    Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF.

  3. Time to Occurrence of All-Cause Death

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

    Registry description

    Time to all-cause death.

  4. Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

  5. Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline

    Time frame · Randomization up to Study Completion (Approximate 248 Weeks)

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

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2026

Rationale, design and baseline characteristics of the TRANSCEND-CKD trial of retatrutide in patients with chronic kidney disease.

Heerspink et al. 2026Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Associationcited by 4

PMID 41160422PMC13218929DOI 10.1093/ndt/gfaf230PUB-41160422

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower * Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: * Coronary artery disease * Cerebrovascular disease * Peripheral arterial disease * Chronic kidney disease defined as: * eGFR \<45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR \>30 milligram/gram (mg/g) (0.030 mg/mg) * eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or * eGFR \<75 mL/min/1.73 m\^2 and UACR \>300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab) * A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: Diabetes related: * Participants have Type 1 Diabetes or any history of diabetic ketoacidosis CV related: * Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization: * Myocardial infarction * Acute coronary syndrome * Stroke, or * Coronary, peripheral, or carotid artery arterial revascularization procedure. * Have acute decompensated heart failure requiring hospitalization. * Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: * Participants have an eGFR \<20 mL/min/1.73 m\^2 at screening * Have UACR \>5000 mg/g (5.000 mg/mg) at screening * Have received any form of dialysis ≤ 90 days from the date of randomization * Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: * Participants have had or plan to have a surgical treatment for obesity, * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 * Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

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