DRUG
Retatrutide
Administered SC
Status
Active, not recruiting
Phase
Phase 3
Enrollment
10,000
Locations
743
Results
Not posted
Publications
1
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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Apr 25, 2024
Study start
Apr 30, 2024
Primary completion
Feb 2029
Study completion
Feb 2029
Results posted
Not reported
Registry updated
Jul 20, 2026
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.
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
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
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
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Related PeptideStat pages
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