Actively Recruiting
Phase 3 Study of Brenipatide Compared to Placebo for Adults with Moderate-to-Severe Alcohol Use Disorder
Led by Eli Lilly and Company · Updated on 2026-08-06
1100
Participants Needed
119
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.
CONDITIONS
Brief Title
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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