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NCT07219953PHASE3Recruiting

A Study of Brenipatide in Participants With Alcohol Use Disorder

Eli Lilly and Company

Start Date

10/16/2025

Completion Date

4/1/2028

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

Age Range: 18 years to 75 years

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 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 or 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).

Interventions

DRUG

LY3537031

DRUG

Placebo

Interested in This Trial?

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Conditions

Alcohol Use Disorder

Locations

Headlands Research - Scottsdale

Scottsdale, Arizona 85260

United States

Woodland International Research Group

Little Rock, Arkansas 72211

United States

UCLA Clinical & Translational Research Center (CTRC)

Los Angeles, California 90095

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Artemis Institute for Clinical Research

San Diego, California 92123

United States

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay

San Francisco, California 94158

United States

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida 33803

United States

Innovative Clinical Research

Lauderhill, Florida 33319

United States

K2 Medical Research - Maitland

Maitland, Florida 32751

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

Life Arc Research Centers - Miami

Miami, Florida 33126

United States

Wellness Research Center

Miami, Florida 33135

United States

Life Medical Research Group Corp

Miami Gardens, Florida 33014

United States

Charter Research - Orlando

Orlando, Florida 32803

United States

K2 Medical Research - Tampa

Tampa, Florida 33634

United States

Re:Cognition Health - Chicago

Chicago, Illinois 60611

United States

Maryland Treatment Centers - Mountain Manor Treatment Center

Baltimore, Maryland 21229

United States

Maryland Treatment Centers - Avery Road Treatment Center

Rockville, Maryland 20853

United States

Adams Clinical Boston

Boston, Massachusetts 02116

United States

K2 Medical Research - Foxborough

Foxborough, Massachusetts 02035

United States

Adams Clinical Bronx

The Bronx, New York 10461

United States

North Star Medical Research

Middleburg Heights, Ohio 44130

United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Brown University School of Public Health

Providence, Rhode Island 02903

United States

Avera Research Institute - Sioux Falls

Sioux Falls, South Dakota 57108

United States

Modern Research Associates, PLLC

Dallas, Texas 75231

United States

Adams Clinical Dallas

DeSoto, Texas 75115

United States

Biopharma Informatic, LLC

Houston, Texas 77043

United States

Re:Cognition Health

Fairfax, Virginia 22031

United States

ANIMA Research

Diepenbeek, 3590

Belgium

Kormont

Kluisbergen, 9690

Belgium

Gezondheidshuis De Gloed

Machelen, 9870

Belgium

Meclinas

Mechelen, 2800

Belgium

Medisch Centrum Saffrou

Oudenaarde, 9636

Belgium

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, 100088

China

Beijing HuiLongGuan Hospital

Beijing, 100096

China

The Second People's Hospital of Hunan Province

Changsha, 410007

China

The Second Xiangya Hospital of Central South University

Changsha, 410011

China

West China Hospital, Sichuan University

Cheng Du Shi, 610041

China

The Fourth People's Hospital of Chengdu

Chengdu, 610036

China

Guangzhou Brain Hospital

Guangzhou, 510370

China

The Seventh People's Hospital of Hangzhou

Hangzhou, 310000

China

Zhejiang Provincial People's Hospital

Hangzhou, 310014

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, 310016

China

The Fourth Hospital of Harbin Medical University

Harbin, 150001

China

Hefei No.4 People's Hospital

Hefei, 230061

China

Huzhou Third Municipal Hospital

Huzhou, 313000

China

Shandong Mental Health Center

Jinan, 250012

China

First Affiliated Hospital of Kunming Medical University

Kunming, 650032

China

The Affilicated Kangning Hospital of Ningbo University

Ningbo, 315201

China

Shanghai Mental Health Center

Shanghai, 200030

China

Shenzhen Kangning Hospital

Shenzhen, 518003

China

The First Hospital of Hebei Medical University

Shijiazhuang, 050031

China

The Affiliated hospital of Southwest Medical University

Sichuan, 646000

China

Wuhu Hospital of Beijing Anding hospital

Wuhu, 242407

China

Xi An Mental Health Center

Xi'an, 710061

China

Xiamen Xianyue Hospital

Xiamen, 361012

China

Xianyang Hospital of Yan'an University

Xianyang, 712000

China

Psychiatric Hospital of Henan Province

Xinxiang, 453003

China

Zhenjiang Mental Health Center

Zhenjiang, 212000

China

Zhumadian Psychiatric Hospital

Zhumadian, 463000

China

FutureMeds GmbH

Berlin, 10629

Germany

Velocity Clinical Research, Berlin

Berlin, 10787

Germany

Klinische Forschung Dresden

Dresden, 01069

Germany

Klinische Forschung Hamburg

Hamburg, 20253

Germany

Zentralinstitut für Seelische Gesundheit

Mannheim, 68159

Germany

Dedicated Research Site FutureMeds

Offenbach, 63065

Germany

Klinische forschung Schwerin GmbH

Schwerin, 19055

Germany

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027

Japan

Ai Sakura Clinic

Fukuoka, 810-0001

Japan

Hiro Mental Clinic

Fukuoka, 810-0004

Japan

Rainbow and Sea Hospital

Karatsu, 847-0031

Japan

Tatsuta Clinic

Kobe, 651-0097

Japan

Arata Clinic

Nagasaki, 852-8137

Japan

Yokogawa Ekimae Clinic

Nishi, 733-0011

Japan

Teine Keijinkai Hospital

Sapporo, 006-0811

Japan

Hillside Clinic Jingumae

Shibuya City, 150-0001

Japan

Samoncho Clinic

Shinjuku, 160-0017

Japan

Keiai Clinic

Shinjuku-ku, 160-0004

Japan

Higashi Shinjuku Clinic

Shinjuku-ku, 169-0072

Japan

Sakurazaka Clinic SophyAnce

Tokyo, 106-0032

Japan

Noguchi Naika Clinic

Tokyo, 165-0031

Japan

Tsukuba University Hospital

Tsukuba, 305-8576

Japan

Maekawa Medical Clinic

Yokohama, 220-0004

Japan

National Hospital Organization Hizen Psychiatric Medical Center

Yoshinogari-cho, Kanzaki-gun, 842-0192

Japan

Hallym University Sacred Heart Hospital

Anyang-si, 14068

South Korea

Pusan National University Yangsan Hospital

Busan, 50612

South Korea

Chungbuk National University Hospital

Cheongju-si, 28644

South Korea

Hanyang University Guri Hospital

Guri-si, 11923

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Kyungpook National University Hospital

Junggu, 41944

South Korea

Gachon University Gil Medical Center

Namdong-gu, 21565

South Korea

Konyang University Hospital

Seogu, 35365

South Korea

Konyang University Hospital

Seogu, 35365

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, 06591

South Korea

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, 11765

South Korea

Changhua Christian Hospital

Changhua County, 50006

Taiwan

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, 970

Taiwan

China Medical University Hospital

Taichung, 404332

Taiwan

Mackay Memorial Hospital

Taipei, 10449

Taiwan

Tri-Service General Hospital

Taipei, 114

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Layton Medical Centre

Blackpool, FY3 7EN

United Kingdom

Clerkenwell Health - Doncaster

Doncaster, DN4 8QN

United Kingdom

St Pancras Clinical Research - Eastbourne

Eastbourne, BN23 5UZ

United Kingdom

Queen Elizabeth University Hospital

Glasgow, G51 4TF

United Kingdom

Mounts Bay Medical Hub

Hayle, TR27 5DT

United Kingdom

HMC Health Group - Meadows Centre for Health

Hounslow, TW4 7NR

United Kingdom

St Pancras Clinical Research

London, EC2Y 8EA

United Kingdom

Clerkenwell Health - London - Baker Street

London, W1U 6RP

United Kingdom

Newquay Health Centre

Newquay, TR7 1RU

United Kingdom

Panthera Biopartners - Preston

Preston, PR2 9QB

United Kingdom

Wickersley Health Centre - Clifton Medical Centre

Rotherham, S65 1DA

United Kingdom