What is brenipatide studying for Alcohol Use Disorder?

Brenipatide is being studied to see if it can help reduce drinking and improve safety for adults with Alcohol Use Disorder. The trial compares brenipatide with a placebo to evaluate changes in drinking patterns over about 56 weeks. This research is sponsored by Eli Lilly and Company.

Who may be eligible for this Alcohol Use Disorder clinical trial?

Adults aged 18 to 75 with Alcohol Use Disorder who are motivated to stop or reduce drinking may be eligible. Participants must be willing to self-inject or accept help with injections and complete study visits. People with recent substance use disorders other than alcohol, nicotine, or caffeine, or recent suicidal behaviors are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Alcohol Use Disorder clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

ID07219953

A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Adult Participants With Alcohol Use Disorder

Led by Eli Lilly and Company · Updated on 2026-06-03

1100

Participants Needed

119

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the drug brenipatide compared to a placebo in adults with Alcohol Use Disorder AUD and hazardous alcohol use. The study aims to assess the drugs effect on drinking patterns and its safety. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and will last about 56 weeks. Participants receive escalating doses of brenipatide or placebo, administered as subcutaneous injections. The study includes a multi-period design with two experimental periods for brenipatide dosing and a placebo group. Participants or trained support persons will perform self-injections, and the study medication is blinded to ensure unbiased results. Throughout the trial, participants will attend regular visits for assessments including drinking behavior using the Timeline Followback Method, alcohol craving scales, health questionnaires, and body weight measurements. Blood samples will be taken to analyze drug levels and immune response. Participants will keep diaries and complete questionnaires to monitor adherence and effects. Safety and tolerability will be closely monitored during the 56-week participation period.

CONDITIONS

Brief Title

A Study of Brenipatide in Participants With Alcohol Use Disorder

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant must be at least 20 years old for sites in Japan
Seeking treatment and motivated to stop or reduce drinking
Willing and able to self-inject study medication or have trained support to help
Able to attend all required study visits and follow study procedures including diaries and questionnaires

You will not qualify if you...

History or current substance use disorder other than alcohol, nicotine, or caffeine within 180 days before screening
Suicidal thoughts or behaviors within the last 6 months based on Columbia-Suicide Severity Rating Scale
History of advanced liver disease or alcohol-related hepatitis
Participation in another clinical trial with active treatment within 90 days or 5 half-lives before screening

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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