NCT07223593招募中3 期
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
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
- 1,205
- 试验地点
- 271
- 主要终点
- Percent Change from Baseline in Maximum Walking Distance
研究概览
简要总结
The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- •Have an Ankle Brachial Index (ABI) of 0.9 or less
排除标准
- •Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)
- •Have Hemoglobin A1c (HbA1c) greater than 10%
- •Have walking ability limited by conditions other than PAD
- •Have a planned lower limb surgery or any other surgery affecting walking ability
- •Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial
- •Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening
- •Have heart failure presently classified as being in New York Heart Association class III - IV
研究组 & 干预措施
Orforglipron
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Maximum Walking Distance
时间窗: Baseline, Week 52
On a constant load treadmill test
次要结局
- Change from Baseline in 6 Minute Walk Test Distance (meters)(Baseline, Week 52)
- Percent Change from Baseline in Pain Free Walking Distance(Baseline, Week 52)
- Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score(Baseline, Week 52)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 52)
- Change from Baseline in Systolic Blood Pressure (mmHg)(Baseline, Week 52)
研究者
研究点 (271)
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