2025-523657-34-00招募中3 期
J3R-MC-YDAG - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 25
- 主要终点
- Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64
研究概览
简要总结
To demonstrate that eloralintide is superior to placebo for change in body weight.
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 obesity or overweight
- •If overweight, must also have one of the following: high blood pressure, high cholesterol, obstructive sleep apnea or heart disease
- •Have a stable body weight (<5% body weight change) for 90 days prior to screening
- •Have at least one self-report of an unsuccessful dietary effort to lose weight
排除标准
- •Have type 1 diabetes or type 2 diabetes
- •Have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)
- •Have had a serious heart condition within 90 days prior to screening
- •Have taken medications or alternative remedies for weight loss within 90 days of screening
研究组 & 干预措施
Eloralintide, Eloralintide, Eloralintide, Eloralintide
Test
干预措施: Eloralintide (Drug)
Placebo to match LY
Placebo
干预措施: Placebo to match LY (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64
Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64
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 (25)
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