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

RecruitingPhase 3

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)

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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 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).

About the study

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 1,100 · Started: Oct 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07219966

Locations in the U.S.

AlabamaParkway Medical Center, Birmingham (Not yet recruiting)
ArizonaHeadlands Research - Scottsdale, Scottsdale
ArkansasWoodland International Research Group, Little Rock
CaliforniaUCLA Clinical & Translational Research Center (CTRC), Los Angeles
Artemis Institute for Clinical Research, San Diego
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay, San Francisco
ColoradoMountain Mind - Denver, Denver
FloridaAccel Research Sites - Lakeland Clinical Research Unit, Lakeland
K2 Medical Research - Maitland, Maitland
K2 Medical Research ORLANDO, Maitland
Life Arc Research Centers - Miami, Miami
Wellness Research Center, Miami
Life Medical Research Group Corp, Miami Gardens
Charter Research - Orlando, Orlando
K2 Medical Research - Tampa, Tampa
IllinoisRe:Cognition Health - Chicago, Chicago
MarylandMaryland Treatment Centers - Mountain Manor Treatment Center, Baltimore
Maryland Treatment Centers - Avery Road Treatment Center, Rockville
MassachusettsAdams Clinical Boston, Boston
K2 Medical Research - Foxborough, Foxborough
New YorkAdams Clinical Bronx, The Bronx
OhioNorth Star Medical Research, Middleburg Heights
PennsylvaniaPenn Medicine: University of Pennsylvania Health System, Philadelphia
South DakotaAvera Research Institute - Sioux Falls, Sioux Falls
TexasUT Southwestern Medical Center, Dallas
Adams Clinical Dallas, DeSoto
Pillar Clinical Research - Richardson, Richardson
UtahAlpine Research Organization, Clinton
VirginiaRe:Cognition Health, Fairfax
WashingtonUniversity of Washington Medical Center - Montlake, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.