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Clinical Trials in the USA / NCT06383390
Active, not recruiting Phase 3

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

NCT06383390 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-04-30
Last updated
2026-08-24

Condition(s) studied

Atherosclerotic Cardiovascular Disease (ASCVD)Chronic Kidney Disease (CKD)

Investigational drug(s) / intervention(s)

RetatrutidePlacebo

Retatrutide: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
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

Primary outcome measure(s)

Trial sites (743)

FacilityCityRegionStatus
Alabama Kidney Research Alabaster Alabama
Central Research Associates Birmingham Alabama
Alliance for Multispecialty Research, LLC Daphne Alabama
Nephrology Consultants Huntsville Alabama
Alliance for Multispecialty Research, LLC Mobile Alabama
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
Sun City Clinical Research Glendale Arizona
Arizona Kidney Disease & Hypertension Center (AKDHC) - Thunderbird Glendale Arizona
Helios Clinical Research - SAZ-PDV-026 Paradise Valley Arizona
Banner University Medical Center Phoenix Phoenix Arizona
Phoenix Clinical LLC Phoenix Arizona
Elite Clinical Studies, LLC Phoenix Arizona
Absolute Clinical Research Phoenix Arizona
Scottsdale Clinical Trials Scottsdale Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West Sun City West Arizona
Synexus Clinical Research US, Inc./Orange Grove Family Practice Tucson Arizona
Cardiology and Medicine Clinic Little Rock Arkansas
Trident Clinical Research Services, Inc. Apple Valley California
Invivo - Bakersfield Bakersfield California
American Institute of Research Beverly Hills California
Hope Clinical Research, Inc. Canoga Park California
Valley Clinical Trials, Inc. Covina California
North Coast Cardiology Encinitas California
Neighborhood Healthcare Institute of Health Escondido California
HB Clinical Trials - Fountain Valley Fountain Valley California
Care Access - Huntington Beach Huntington Beach California
Irvine Clinical Research Irvine California
Scripps Whittier Diabetes Institute La Jolla California
Long Beach Research Institute Long Beach California
Ark Clinical Research Long Beach California
North America Research Institute Lynwood California
Valley Clinical Trials, Inc. Northridge California
Desert Oasis Healthcare Medical Group Palm Springs California
California Liver Research Institute Pasadena California
Western University of Health Sciences Pomona California
California Kidney Specialists San Dimas California
Southern California Clinical Research Santa Ana California
Care Access - Santa Clarita Santa Clarita California
Encompass Clinical Research Spring Valley California
Valiance Clinical Research Tarzana California

+ 703 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06383390 on ClinicalTrials.gov ↗ ← All trials in the USA