Overview
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
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