A Study of Brenipatide in Participants With Alcohol Use Disorder

Last updated: March 19, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Alcohol Dependence

Addictions

Alcohol Use Disorder

Treatment

Placebo

LY3537031

Clinical Study ID

NCT07219953
27410
2025-522312-16-00
J2S-MC-GZMP
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be a minimum of 20 years of age for the investigative sites inJapan.

  • 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 studyand attend required study visits, and are willing and able to follow studyprocedures as required, such as

  • self-inject study intervention Note: Participants who are not able to performthe injections must receive assistance from a support person trained toadminister 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

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 ofpersistent illicit or nonprescribed substance use as indicated by clinicalinterview, 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 ideationoccurred within the past 6 months, or Have answered "yes" to any of thesuicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and thebehavior occurred within the past 6 months

  • Have a history of advanced liver disease (including advanced liver fibrosis orcirrhosis), or alcohol associated hepatitis based on either prior liver histology orimaging 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 unknownif they received active treatment, within 90 days or 5 half-lives (whichever islonger) before screening (V1).

Study Design

Total Participants: 1100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 16, 2025
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • CIPREC

    Buenos Aires 3435910, 1061
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires 3435910, C1056ABI
    Argentina

    Site Not Available

  • Fundación Respirar

    Buenos Aires 3435910, C1426ABP
    Argentina

    Site Not Available

  • Mautalen Salud e Investigación

    Buenos Aires 3435910, C1128AAF
    Argentina

    Site Not Available

  • Centro Médico Luquez

    Córdoba 3860259, X5006CBI
    Argentina

    Site Not Available

  • Instituto Kremer

    Córdoba 3860259, X5004AOA
    Argentina

    Site Not Available

  • Sanatorio Morra S.A.

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • Global Psy Asociación Civil

    La Plata 3432043, 1904
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata 3430863, B7600FZO
    Argentina

    Site Not Available

  • Resolution Psychopharmacology Research Institute

    Mendoza 3844421, 5502
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Fundación Innovaciencia

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario 3838583, S2000CVD
    Argentina

    Site Not Available

  • Centro de Diagnóstico y Rehabilitación (CEDIR)

    Santa Fe 3836277, 3000
    Argentina

    Site Not Available

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

    Santa Fe 3836277, 3000
    Argentina

    Site Not Available

  • Clinica El Jardin

    Santiago del Estero 3835869, 4200
    Argentina

    Site Not Available

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    Alken 2803285, 3570
    Belgium

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    Kluisbergen, 9690
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    Machelen, 9870
    Belgium

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    Machelen 2791951, 9870
    Belgium

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    Mechelen, 2800
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  • Meclinas

    Mechelen 2791537, 2800
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    Incheon, 22332
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    Site Not Available

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    Baltimore 4347778, Maryland 4361885 21229
    United States

    Site Not Available

  • Maryland Treatment Centers - Avery Road Treatment Center

    Rockville 4367175, Maryland 4361885 20853
    United States

    Site Not Available

  • Adams Clinical Boston

    Boston, Massachusetts 02116
    United States

    Active - Recruiting

  • Adams Clinical Boston

    Boston 4930956, Massachusetts 6254926 02116
    United States

    Site Not Available

  • Adams Clinical Bronx

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Adams Clinical Bronx

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • North Star Medical Research

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • North Star Medical Research

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Site Not Available

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • K2 Medical Research - East Providence

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Brown University School of Public Health

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • K2 Medical Research - East Providence

    East Providence 5221931, Rhode Island 5224323 02914
    United States

    Site Not Available

  • Brown University School of Public Health

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Avera Research Institute - Sioux Falls

    Sioux Falls 5231851, South Dakota 5769223 57108
    United States

    Site Not Available

  • Modern Research Associates, PLLC

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Adams Clinical Dallas

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Modern Research Associates, PLLC

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Adams Clinical Dallas

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77043
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Re:Cognition Health

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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