GZME
Research type
Research Study
Full title
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
IRAS ID
1012505
Contact name
Emily Coss
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
The purpose of this study is to assess the efficacy and safety of brenipatide at different dose levels (0.3 mg, 0.75 mg, and 1.5 mg QW) compared with placebo in participants with moderate to severe Alcohol Use Disorder (AUD). The results from this study will help researchers to decide on how to continue developing brenipatide in the future.
This study includes the following study periods:
screening period
treatment period (Period I): 32 weeks of study treatment including a dose escalation period
randomized withdrawal extension period (Period II), and
posttreatment safety follow-up period.
The study will enroll participants from 18 to 75 years of age (inclusive) with moderate-to-severe AUD and hazardous alcohol use. Study participants will be excluded based on conditions that could interfere with study assessments or increase a participant’s risk of experiencing side effects during the study.
Approximately 1100 participants will be randomly assigned to the study drug or placebo.REC name
London - Central Research Ethics Committee
REC reference
25/LO/0699
Date of REC Opinion
27 Nov 2025
REC opinion
Further Information Favourable Opinion