2024-517431-43-00招募中3 期
J1I-MC-GZQD: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)
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
- 7
- 主要终点
- Change from Baseline in Weekly Average Pain Intensity-Numeric Rating Scale (API-NRS) Score [Time Frame: Baseline, up to 72 weeks]
研究概览
简要总结
To demonstrate that retatrutide MTD is superior to placebo for change in average pain intensity and 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
- 是
入选标准
- •Have had low back pain for at least the last 6 months
- •Be overweight
- •Have tried to lose weight by changing what they eat but it did not work
排除标准
- •Have a change in body weight greater than 11 pounds.
- •Have diabetes
- •Have prior history of low back surgery
结局指标
主要结局
Change from Baseline in Weekly Average Pain Intensity-Numeric Rating Scale (API-NRS) Score [Time Frame: Baseline, up to 72 weeks]
Change from Baseline in Weekly Average Pain Intensity-Numeric Rating Scale (API-NRS) Score [Time Frame: Baseline, up to 72 weeks]
Percent Change from Baseline in Body Weight [Time Frame: Baseline, up to 72 weeks]
Percent Change from Baseline in Body Weight [Time Frame: Baseline, up to 72 weeks]
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 (7)
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