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Brenipatide for moderate-to-severe alcohol use disorder

A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Phase 3 Interventional Eli Lilly and Company · NCT07219966

This trial will test whether brenipatide is safe and helps adults with moderate-to-severe alcohol use disorder who want to stop or cut down drinking.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations119 sites (Birmingham, Alabama and 118 other locations)
Trial IDNCT07219966 on ClinicalTrials.gov

What this trial studies

In this phase 3, placebo-controlled trial participants will be randomly assigned to receive either brenipatide (LY3537031) or a matching placebo and followed for about 56 weeks. Participants will self-administer the blinded injections, complete electronic and paper diaries, and attend regular clinic visits to record drinking, symptoms, and side effects. Safety monitoring and standardized questionnaires will be used to track outcomes over the treatment period. The trial is sponsored by Eli Lilly and conducted at multiple clinical research sites.

Who should consider this trial

Good fit: Adults with moderate-to-severe alcohol use disorder who are motivated to stop or cut down drinking, willing to self-inject study medication, keep study diaries, and attend regular visits for roughly 56 weeks, and who do not have recent uncontrolled non-alcohol substance use or active suicidal ideation.

Not a fit: People with recent or ongoing non-alcohol substance use disorders, active suicidal ideation, inability to self-inject or commit to long-term follow-up, or other exclusionary medical/psychiatric conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, brenipatide could reduce drinking and support longer-term abstinence or reduced alcohol use in people with moderate-to-severe AUD.

How similar studies have performed: Some early-stage studies of related compounds have suggested potential for reducing alcohol intake, but large confirmatory phase 3 evidence for this approach is still emerging.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.
* 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).

Where this trial is running

Birmingham, Alabama and 118 other locations

+69 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alcohol Use Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.