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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10,000
Administered SC
Administered SC
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
Time to First Occurrence of Composite Endpoints
A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).
Time frame: Randomization up to Study Completion (Approximate 248 Weeks)
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
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 frame: Randomization up to Study Completion (Approximate 248 Weeks)
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)
MACE-3 includes CV death, nonfatal MI, and nonfatal stroke.
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 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 Occurrence of All-Cause Death
Time to all-cause death.
Time frame: Randomization up to Study Completion (Approximate 248 Weeks)
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)
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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
...and 735 more locations