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

Last updated: April 16, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Alcohol Dependence

Substance Abuse

Addictions

Treatment

LY3537031

Placebo

Clinical Study ID

NCT07219966
27346
JS2-MC-GZME
J2S-MC-GZME
2025-522313-38-00
  • 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 moderate-to-severe Alcohol Use Disorder (AUD). 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

  • 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: LY3537031
Phase: 3
Study Start date:
October 15, 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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    Diepenbeek, 3590
    Belgium

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    Diepenbeek 2799412, 3590
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    Kluisbergen, 9690
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    Machelen, 9870
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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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    Xianyang 1790353, 712000
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    Xinxiang, 453003
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    Zhenjiang 1784642, 212000
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    Berlin, 10629
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    Berlin, 10787
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    Hamburg, 20253
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    Hamburg 2911298, 20253
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    Mannheim, 68159
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    Mannheim 2873891, 68159
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    Germany

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    Schwerin, 19055
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    Schwerin 2834282, 19055
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  • Takahashi Psychiatric Clinic

    Ashiya, 659-0093
    Japan

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    Ashiya 1864985, 659-0093
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    Chūōku, 103-0027
    Japan

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    Chūōku 10262791, 103-0027
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    Fukuoka 1863967, 810-0001
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    Kariya, 448-0851
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    Kariya 1860034, 448-0851
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    Kobe, 651-0097
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    Kobe 1859171, 651-0097
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    Nagasaki, 852-8137
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    Nagasaki 1856177, 852-8137
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    Nishi, 733-0011
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  • Yokogawa Ekimae Clinic

    Nishi 1855356, 733-0011
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  • Teine Keijinkai Hospital

    Sapporo, 006-0811
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    Sapporo 2128295, 006-0811
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    Setagaya City, 154-0004
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    Setagaya City 11790342, 154-0004
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    Shibuya City, 150-0001
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  • Kaedenomori Mental Clinic

    Shibuya City, 150-0022
    Japan

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  • Hillside Clinic Jingumae

    Shibuya City 11808021, 150-0001
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  • Kaedenomori Mental Clinic

    Shibuya City 11808021, 150-0022
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    Shinjuku, 160-0017
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    Shinjuku 11790353, 160-0017
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    Shinjuku-ku, 169-0072
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    Tokyo, 165-0031
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    Tokyo 1850147, 106-0032
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    Tsukuba, 305-8576
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    Tsukuba 2110681, 305-8576
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    Yokohama, 220-0004
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    Yoshinogari-cho, Kanzaki-gun, 842-0192
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    Anyang-si, 14068
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    Busan, 50612
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    Busan 1838524, 50612
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    Cheongju-si, 28644
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    Cheongju-si 1845604, 28644
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    Guri-si, 11923
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    Incheon, 22332
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    United States

    Active - Recruiting

  • Life Medical Research Group Corp

    Miami Gardens 4164167, Florida 4155751 33014
    United States

    Site Not Available

  • Charter Research - Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • K2 Medical Research - Tampa

    Tampa 4174757, Florida 4155751 33634
    United States

    Site Not Available

  • Re:Cognition Health - Chicago

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Re:Cognition Health - Chicago

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Maryland Treatment Centers - Avery Road Treatment Center

    Rockville, Maryland 20853
    United States

    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

  • K2 Medical Research - East Providence

    East Providence 5221931, Rhode Island 5224323 02914
    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

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Adams Clinical Dallas

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Pillar Clinical Research - Richardson

    Richardson, Texas 75080
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Adams Clinical Dallas

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Pillar Clinical Research - Richardson

    Richardson 4722625, Texas 4736286 75080
    United States

    Site Not Available

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Alpine Research Organization

    Clinton 5773001, Utah 5549030 84015
    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

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • University of Washington Medical Center - Montlake

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

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