Actively Recruiting
Phase 3 Trial of Brenipatide Injection Compared to Placebo for Adults with Alcohol Use Disorder
Led by Eli Lilly and Company · Updated on 2026-08-06
1100
Participants Needed
116
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.
CONDITIONS
Brief Title
A Study of Brenipatide in Participants With Alcohol Use Disorder
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
