J2A-MC-GZPW: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established 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
- 548
- 试验地点
- 51
- 主要终点
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]
研究概览
简要总结
To demonstrate whether orforglipron is superior to placebo in reducing the risk for major CV events.
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
- •Have heart disease, kidney disease, or both
排除标准
- •Have type 1 diabetes
- •Have had a serious heart condition within 60 days of screening
- •Have New York Heart Association Functional Classification Class IV heart failure
结局指标
主要结局
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.