NCT07219953招募中3 期
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 Alcohol Use Disorder (RENEW-ALC-2)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 236
- 主要终点
- Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
研究概览
简要总结
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be a minimum of 20 years of age for the investigative sites in Japan.
- •Are seeking treatment and are motivated to stop or cut down on drinking.
- •Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
- •self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention.
- •store and use the provided blinded study intervention, as directed
- •maintain electronic and paper study diaries, as applicable, and
- •complete the required questionnaires.
排除标准
- •Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.
- •Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
- •Have either of the following:
- •history of advanced liver disease, including advanced liver fibrosis [Stage 3] or cirrhosis [Stage 4], based on prior biomarkers, imaging or liver biopsy, OR
- •history of acute or alcohol-associated hepatitis based on prior liver biopsy.
- •Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).
研究组 & 干预措施
Placebo
Placebo Comparator
Administered SC
干预措施: Placebo (Drug)
LY3537031 Period 2
Experimental
Administered SC
干预措施: Placebo (Drug)
LY3537031 Period 1
Experimental
Escalating doses administered subcutaneously (SC)
干预措施: LY3537031 (Drug)
LY3537031 Period 2
Experimental
Administered SC
干预措施: LY3537031 (Drug)
LY3537031 Period 1
Experimental
Escalating doses administered subcutaneously (SC)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
时间窗: Up to 56 weeks
次要结局
- Change in Daily Alcohol Consumption as Assessed by the TLFB(Up to 56 weeks)
- Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)(Baseline up to Week 56)
- Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score(Baseline up to Week 56)
- Mean Change in Body Weight(Baseline up to Week 56)
- Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores(Baseline up to Week 56)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 56)
- Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)(Baseline up to Week 56)
研究者
研究点 (236)
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