What is brenipatide studying for Alcohol Use Disorder?

Brenipatide is being studied to see if it changes drinking patterns and is safe for adults with moderate-to-severe Alcohol Use Disorder. Researchers want to understand if this medication can help reduce alcohol use. The study is sponsored by Eli Lilly and Company and involves carefully monitored treatment over about 56 weeks.

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

Adults aged 18 to 75 years with moderate-to-severe Alcohol Use Disorder who are seeking treatment and motivated to reduce or stop drinking may be eligible. Participants must be willing to self-inject the study drug and follow study procedures. People with recent illicit drug use disorders 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 and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside of the study itself.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

ID07219966

A Phase 3, Randomized, Double-Blind Study Comparing Brenipatide With Placebo for Adults With Moderate-to-Severe Alcohol Use Disorder

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

1100

Participants Needed

123

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating brenipatide, compared to a placebo, in adults with moderate-to-severe Alcohol Use Disorder AUD. This study aims to assess how brenipatide affects drinking patterns and its safety over a period of approximately 56 weeks. The trial is a phase 3, multicenter, randomized, double-blind study sponsored by Eli Lilly and Company. Participants will receive escalating doses of brenipatide or placebo, administered by subcutaneous injection. The study includes multiple experimental periods where participants receive the study drug or placebo under controlled conditions. The dosing is carefully monitored to assess the drugs effects compared to placebo. During the study, participants will undergo regular assessments including drinking behavior tracked by the Timeline Followback Method, craving levels measured by the Penn Alcohol Craving Scale, and health outcomes collected through questionnaires. Safety will be monitored by evaluating laboratory tests and adverse events. The total participation lasts up to 56 weeks with ongoing monitoring throughout this period.

CONDITIONS

Brief Title

A Study of Brenipatide in Participants With Moderate-to-Severe 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 at investigative sites in Japan
Seeking treatment and motivated to stop or cut down on drinking
Willing and able to make themselves available for the study duration and attend required visits
Able and willing to self-inject the study intervention
Able and willing to store and use the blinded study intervention as directed
Willing to maintain electronic and paper study diaries as applicable
Able to complete required questionnaires

You will not qualify if you...

Evidence of substance use disorder involving illicit or nonprescribed drugs within 180 days prior to screening, except alcohol, nicotine, or caffeine
Suicidal ideation or behavior within the past 6 months as indicated by the Columbia-Suicide Severity Rating Scale
History of advanced liver disease or alcohol-associated hepatitis based on histology or imaging
Participation in another clinical study 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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