2025-522313-38-00招募中3 期
J2S-MC-GZME: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 5
- 主要终点
- Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
研究概览
简要总结
Period 1 Primary Objective To demonstrate that at least 1 dose level of brenipatide is superior to placebo for at least 1 of the dual primary endpoints
Period 2 Primary Objective For brenipatide responders from Period 1: To evaluate the ability of brenipatide (pooled across doses) to maintain a general reduction in alcohol consumption endpoint
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Motivated to stop or cut down on drinking.
- •Willing to take part in the whole study and go to all the needed visits
- •Willing to do what the study asks, like giving yourself the medicine, keeping and using the medicine as told, writing in study diaries, and answering questions.
排除标准
- •Used or currently use illegal drugs or medicines that were not prescribed to you in the past 180 days. This does not include alcohol, nicotine, or caffeine.
- •Had serious liver problems in the past, like bad liver scarring (fibrosis or cirrhosis) or liver disease caused by alcohol, based on past liver tests or scans (like ultrasound, CT, MRI, or special blood tests).
结局指标
主要结局
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
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 (5)
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