2025-523769-11-00招募中3 期
J3R-MC-YDAO - A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight (ENLIGHTEN-3) Intervention-Specific Appendices (ISAs): J3R-MC-YSA1: Participants unable or unwilling to use positive airway pressure therapy J3R-MC-YSA2: Participants treated with positive airway pressure therapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 169
- 试验地点
- 17
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
To demonstrate that eloralintide is superior to placebo for change in body weight and apnea-hypopnea index.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed history of moderate-to-severe obstructive sleep apnea (OSA)
- •Have a stable body weight (<5% body weight change) for 90 days prior to screening
- •Have an Apnea-Hypopnea Index (AHI) ≥ 15 on polysomnography (PSG) as part of the study at screening
- •For YSA1 participants: be unable or unwilling to use positive airway pressure (PAP) therapy
- •For YSA2 participants: have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study
排除标准
- •Have had or are planning to have surgery, an endoscopic procedure, and/or devicebased therapy for weight loss (with exceptions)
- •Have had or are planning to have surgery for sleep apnea or major ear, nose, or throat surgery that still may affect breathing at the time of screening
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Have had a serious heart condition within 90 days prior to screening
- •Have taken medications or alternative remedies intended for weight loss within 90 days prior to screening
研究组 & 干预措施
Placebo to match LY
Placebo
干预措施: Placebo to match LY (Drug)
Eloralintide, Eloralintide, Eloralintide, Eloralintide
Test
干预措施: Eloralintide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
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 (17)
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