A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants With Body Mass Index >27 kg/m^2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.
S
Suparna C. Clasen, MD, MSCE
Primary Investigator
Recruiting
45 years or above
All
Phase
3
10 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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.
Detailed description of study
What will happen during the study?
Experimental: Retatrutide
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
Placebo Comparator: Placebo
Participants will receive matching placebo administered SC.
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
Placebo Comparator: Placebo
Participants will receive matching placebo administered SC.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Overweight, Obesity
-
Age: 45 years or above
-
Gender: All
Inclusion Criteria:
- A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
- Participants may be with or without type 2 diabetes (T2D) unless 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)
- eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or
- eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)
Exclusion Criteria:
- Diabetes related:
- Participants have Type 1 Diabetes or 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 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
Updated on
26 Feb 2025.
Study ID: ECRO-LILLY-TRIUMPH-OUTCOMES, 22299
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