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Brenipatide treatment for people with 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 Alcohol Use Disorder (RENEW-ALC-2)

Phase 3 Interventional Eli Lilly and Company · NCT07219953

This trial will see if brenipatide helps adults with alcohol use disorder reduce drinking and is safe compared with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations114 sites (Scottsdale, Arizona and 113 other locations)
Trial IDNCT07219953 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares brenipatide with a placebo in adults with alcohol use disorder who want to stop or cut down drinking. Participants will be assigned to receive either brenipatide or placebo and will self-administer the blinded injections (or have a trained support person assist) while attending regular clinic visits over about 56 weeks. Study procedures include keeping electronic and paper diaries, completing questionnaires, and safety monitoring throughout the treatment period. People with recent persistent illicit or nonprescribed substance use are excluded.

Who should consider this trial

Good fit: Adults with alcohol use disorder who are motivated to stop or cut down drinking, willing to self-inject (or have trained assistance), and able to attend study visits for the full 56-week period are ideal candidates.

Not a fit: People with recent active non-alcohol substance use disorders, those unwilling or unable to perform or receive injections, or those with disqualifying medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, brenipatide could offer a new medication option that helps reduce drinking and supports recovery in people with alcohol use disorder.

How similar studies have performed: Other medications have shown benefit for some people with alcohol use disorder, but brenipatide is a novel investigational agent with limited prior clinical data in this condition.

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 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 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

Scottsdale, Arizona and 113 other locations

+64 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.