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A Study of Brenipatide for Alcohol Use Disorder

This study is testing a drug called brenipatide to see if it is safe and effective for people with Alcohol Use Disorder (AUD) or hazardous alcohol use. You would receive either brenipatide or a placebo (an inactive substance) through injections under the skin. Researchers will look at changes in your drinking patterns over about 56 weeks to see if brenipatide helps. To join, you must be between 18 and 75 years old (or at least 20 in Japan), seeking treatment, and willing to follow study procedures, including self-injecting. The current status of this study is unclear, and it plans to enroll about 1100 participants.

Study design
This is an interventional study comparing brenipatide to a placebo. It plans to enroll about 1100 participants.
What's involved
You would participate for approximately 56 weeks, attending required study visits and self-injecting the study medication.
Compensation
Not stated in the trial record.
Follow-up
Your drinking patterns will be 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.

NCT07219953

A Study of Brenipatide in Participants With 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
116 of 116 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

116 sites across 21 states
China27
Japan16
South Korea15
United Kingdom11
Florida9
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 Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the 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 or 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