Current partner codePEPTIDESDE
NCT06383390·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

10,000

Locations

743

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Retatrutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Apr 25, 2024

  2. Study start

    Apr 30, 2024

  3. Primary completion

    Feb 2029

  4. Study completion

    Feb 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Time to First Occurrence of Composite Endpoints

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

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

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)

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

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

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

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

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)

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

Time to Occurrence of All-Cause Death

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

Time to all-cause death.

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)

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)

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

743 registered sites.

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 · United States. Showing up to 24 locations stored in the fast local snapshot.

Alabama Kidney Research

Alabaster, Alabama, United States

Central Research Associates

Birmingham, Alabama, United States

Alliance for Multispecialty Research, LLC

Daphne, Alabama, United States

Nephrology Consultants

Huntsville, Alabama, United States

Alliance for Multispecialty Research, LLC

Mobile, Alabama, United States

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC

Gilbert, Arizona, United States

Sun City Clinical Research

Glendale, Arizona, United States

Arizona Kidney Disease & Hypertension Center (AKDHC) - Thunderbird

Glendale, Arizona, United States

Helios Clinical Research - SAZ-PDV-026

Paradise Valley, Arizona, United States

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Phoenix Clinical LLC

Phoenix, Arizona, United States

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Absolute Clinical Research

Phoenix, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Clinical Research Institute of Arizona (CRI) - Sun City West

Sun City West, Arizona, United States

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Tucson, Arizona, United States

Cardiology and Medicine Clinic

Little Rock, Arkansas, United States

Trident Clinical Research Services, Inc.

Apple Valley, California, United States

Invivo - Bakersfield

Bakersfield, California, United States

American Institute of Research

Beverly Hills, California, United States

Hope Clinical Research, Inc.

Canoga Park, California, United States

Valley Clinical Trials, Inc.

Covina, California, United States

North Coast Cardiology

Encinitas, California, United States

Neighborhood Healthcare Institute of Health

Escondido, California, United States

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.