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/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 19
- 主要终点
- 1. Time to First Occurrence of Composite Endpoints (includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF)).
研究概览
简要总结
Retatrutide has the potential of demonstrating clinically meaningful improvements in long-term outcomes associated with obesity. The proposed Study GZBO is designed to characterize the effect of retatrutide on cardiovascular outcomes, kidney outcomes, and kidney function. The primary objectives of this trial are to assess the reduction of risk of the following events in participants with body mass index (BMI) of more than 27 kg/m2 and established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD):
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Incidence of cardiovascular (CV) events, including CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events that result in hospitalization or urgent visits.
-
Incidence of kidney events, including end-stage kidney disease (ESKD), sustained decline of estimated glomerular filtration rate (eGFR) of more than 40%, CV death or renal death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •A Body Mass Index of more than 27.0 kilograms per meter squared.
- •Participants may be with or without T2D unless their 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, or chronic kidney disease.
排除标准
- •Have T1D or history of diabetic ketoacidosis.
- •Have any of the following cardiovascular conditions 90 days or less, prior to randomization: myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure, or have New York Heart Association (NYHA) Classification Class 4 heart failure at screening.
- •Have an eGFR less than 20 mL/min/1.73 meter squared or UACR more than 5000 mg/g at screening, or have received dialysis 90 days or less from the date of randomization, or have undergone a kidney transplant or have a scheduled transplant.
- •Have had or plan to have a surgical treatment for obesity.
- •Have a history of chronic or acute pancreatitis, or history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2, or have a clinically significant gastric emptying abnormality.
结局指标
主要结局
1. Time to First Occurrence of Composite Endpoints (includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF)).
时间窗: 1. Randomization up to Study Completion (Approximate 248 Weeks) | 2. Randomization up to Study Completion (Approximate 248 Weeks)
2. 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.
时间窗: 1. Randomization up to Study Completion (Approximate 248 Weeks) | 2. Randomization up to Study Completion (Approximate 248 Weeks)
次要结局
- 1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) (includes CV death, nonfatal MI, and nonfatal stroke).(2. Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to heart failure (HF).)
研究者
Dr Manish Mistry
Eli Lilly and Company (India) Pvt. Ltd.