J1I-MC-GZBO: 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 Major Adverse Kidney Events 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
- 入组人数
- 2,716
- 试验地点
- 257
- 主要终点
- 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)
研究概览
简要总结
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 and kidney outcomes.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Must be 45 years old or older
- •Have BMI of >27.0 kg/m2
- •Have established ASCVD and/or CKD
- •With or without T2D as long as HbA1c<10%
排除标准
- •Have Type 1 Diabetes
- •Have had or plan to have a surgical treatment for obesity
- •Have an eGFR <20 mL/min/1.73 m2 at screening
- •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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
- •Have acute decompensated heart failure requiring hospitalization
- •Have New York Heart Association (NYHA) Classification Class IV heart failure at screening
研究组 & 干预措施
Placebo Injection
干预措施: Placebo Injection (Drug)
Retatrutide, Retatrutide, Retatrutide, Retatrutide, Retatrutide
干预措施: Retatrutide (Drug)
结局指标
主要结局
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 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 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 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
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.