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A Study of Brenipatide for Moderate-to-Severe Alcohol Use Disorder

This study is testing a drug called brenipatide to see if it is safe and effective for people with moderate-to-severe Alcohol Use Disorder (AUD). You might be able to join if you are between 18 and 75 years old, are seeking treatment for your drinking, and are willing to follow study procedures like self-injecting. The study will compare brenipatide to a placebo (an inactive substance) to see if it changes drinking patterns over about 56 weeks. The study plans to enroll 1100 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 1100 participants. It compares brenipatide to a placebo.
What's involved
You would participate for approximately 56 weeks, attend required study visits, and be willing and able to self-inject.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring changes in drinking patterns, is assessed for up to 56 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219966

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Eli Lilly and Company
~1,100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY3537031Placebo

At a glance

Recruiting sites
75 of 118 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Measured over Up to 56 weeks

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

118 sites across 24 states
China27
Japan20
South Korea13
United Kingdom10
Florida8
Germany7
Taiwan6
Belgium5

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be a minimum of 20 years of age for the investigative sites in Japan.
Are seeking treatment and are motivated to stop or cut down on drinking.
Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
self-inject study intervention
store and use the provided blinded study intervention, as directed
maintain electronic and paper study diaries, as applicable, and
complete the required questionnaires.

Exclusion

Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.
Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
Have either of the following:
history of advanced liver disease, including advanced liver fibrosis \[Stage 3\] or cirrhosis \[Stage 4\], based on prior biomarkers, imaging or liver biopsy, OR
history of acute alcohol-associated hepatitis based on prior liver biopsy.
Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).

What this trial measures

  • Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)Up to 56 weeks