CTRI/2026/04/107819尚未招募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
Eli Lilly and Company (India) Pvt. Ltd.8 个研究点 分布在 1 个国家目标入组 1,205 人开始时间: 2026年6月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,205
- 试验地点
- 8
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
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 6.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.
研究者
Dr Rahul Kapur
Eli Lilly and Company (India) Pvt. Ltd
研究点 (8)
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