2025-523283-21-00招募中3 期
J2A-MC-GZPR: A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants with Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 9
- 主要终点
- Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [Time Frame: Baseline, Week 52]
研究概览
简要总结
To demonstrate that orforglipron is superior to placebo in increasing maximum walking distance.
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 symptoms of Peripheral Artery Disease (PAD), causing pain when you walk
排除标准
- •Have a BMI less than 23 kg/m2
- •Have HbA1c greater than 10%
- •Have had or plan to have a leg surgery to improve blood flow in your legs
- •Have had a heart condition within 60 days prior to screening
结局指标
主要结局
Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [Time Frame: Baseline, Week 52]
Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [Time Frame: Baseline, Week 52]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (9)
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