NCT07241390招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7,140
- 试验地点
- 1,011
- 主要终点
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
研究概览
简要总结
The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have established ASCVD and/or CKD
排除标准
- •Have type 1 diabetes
- •Have had a major heart condition within 60 days prior to screening
- •Have New York Heart Association Functional Classification Class IV heart failure
研究组 & 干预措施
Orforglipron
Experimental
Participants will receive orforglipron orally + standard of care
干预措施: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally + standard of care
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
时间窗: Baseline up to end of study (about 5 years)
Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death
次要结局
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events(Baseline up to end of study (about 5 years))
- Change from Baseline in Total eGFR Slope(Baseline up to end of study (about 5 years))
- Time to Onset of Type 2 Diabetes(Baseline up to end of study (about 5 years))
研究者
研究点 (1011)
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