RecruitingPhase 3NCT07219966

A Study of Brenipatide in Participants With Moderate-to-Severe 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 Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Sponsor

Eli Lilly and Company

Enrollment

1,100 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Alcohol Use Disorder

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LY3537031 and a drug called Placebo for people with alcohol use disorder. The study is currently recruiting participants at 123 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3537031

Administered SC

DRUGPlacebo

Administered SC

Locations(123)

Parkway Medical Center

Birmingham, Alabama, United States

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Woodland International Research Group

Little Rock, Arkansas, United States

UCLA Clinical & Translational Research Center (CTRC)

Los Angeles, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

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

San Francisco, California, United States

Mountain Mind - Denver

Denver, Colorado, United States

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, United States

K2 Medical Research - Maitland

Maitland, Florida, United States

K2 Medical Research ORLANDO

Maitland, Florida, United States

Life Arc Research Centers - Miami

Miami, Florida, United States

Wellness Research Center

Miami, Florida, United States

Life Medical Research Group Corp

Miami Gardens, Florida, United States

Charter Research - Orlando

Orlando, Florida, United States

K2 Medical Research - Tampa

Tampa, Florida, United States

Re:Cognition Health - Chicago

Chicago, Illinois, United States

Maryland Treatment Centers - Mountain Manor Treatment Center

Baltimore, Maryland, United States

Maryland Treatment Centers - Avery Road Treatment Center

Rockville, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

K2 Medical Research - Foxborough

Foxborough, Massachusetts, United States

Adams Clinical Bronx

The Bronx, New York, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Avera Research Institute - Sioux Falls

Sioux Falls, South Dakota, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Adams Clinical Dallas

DeSoto, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Re:Cognition Health

Fairfax, Virginia, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

ANIMA Research

Diepenbeek, Belgium

Kormont

Kluisbergen, Belgium

Gezondheidshuis De Gloed

Machelen, Belgium

Meclinas

Mechelen, Belgium

Medisch Centrum Saffrou

Oudenaarde, Belgium

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, China

Beijing HuiLongGuan Hospital

Beijing, China

The Second People's Hospital of Hunan Province

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

West China Hospital, Sichuan University

Cheng Du Shi, China

The Fourth People's Hospital of Chengdu

Chengdu, China

Guangzhou Brain Hospital

Guangzhou, China

The Seventh People's Hospital of Hangzhou

Hangzhou, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

The Fourth Hospital of Harbin Medical University

Harbin, China

Huzhou Third Municipal Hospital

Huzhou, China

Shandong Mental Health Center

Jinan, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

The Third Hospital of Mianyang

Mianyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Affilicated Kangning Hospital of Ningbo University

Ningbo, China

Shanghai Mental Health Center

Shanghai, China

Shenzhen Kangning Hospital

Shenzhen, China

The First Hospital of Hebei Medical University

Shijiazhuang, China

The Affiliated hospital of Southwest Medical University

Sichuan, China

Tianjin Anding Hospital

Tianjin, China

Wuhu Hospital of Beijing Anding hospital

Wuhu, China

Xi An Mental Health Center

Xi'an, China

Xiamen Xianyue Hospital

Xiamen, China

Xianyang Hospital of Yan'an University

Xianyang, China

Psychiatric Hospital of Henan Province

Xinxiang, China

Zhenjiang Mental Health Center

Zhenjiang, China

FutureMeds GmbH

Berlin, Germany

Velocity Clinical Research, Berlin

Berlin, Germany

Klinische Forschung Dresden

Dresden, Germany

Klinische Forschung Hamburg

Hamburg, Germany

Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Dedicated Research Site FutureMeds

Offenbach, Germany

Klinische forschung Schwerin GmbH

Schwerin, Germany

Takahashi Psychiatric Clinic

Ashiya, Japan

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Ai Sakura Clinic

Fukuoka, Japan

Hiro Mental Clinic

Fukuoka, Japan

Kuramitsu Hospital

Fukuoka, Japan

Rainbow and Sea Hospital

Karatsu, Japan

Kariya Hospital

Kariya, Japan

Tatsuta Clinic

Kobe, Japan

Arata Clinic

Nagasaki, Japan

Yokogawa Ekimae Clinic

Nishi, Japan

Teine Keijinkai Hospital

Sapporo, Japan

Sangenjaya Shinkeika Shinryonaika Clinic

Setagaya City, Japan

Hillside Clinic Jingumae

Shibuya City, Japan

Kaedenomori Mental Clinic

Shibuya City, Japan

Samoncho Clinic

Shinjuku, Japan

Keiai Clinic

Shinjuku-ku, Japan

Higashi Shinjuku Clinic

Shinjuku-ku, Japan

Sakurazaka Clinic SophyAnce

Tokyo, Japan

Noguchi Naika Clinic

Tokyo, Japan

Tsukuba University Hospital

Tsukuba, Japan

Maekawa Medical Clinic

Yokohama, Japan

Makoto Kokoro No Clinic

Yokohama, Japan

National Hospital Organization Hizen Psychiatric Medical Center

Yoshinogari-cho, Kanzaki-gun, Japan

Hallym University Sacred Heart Hospital

Anyang-si, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

Chungbuk National University Hospital

Cheongju-si, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

Inha University Hospital

Incheon, South Korea

Kyungpook National University Hospital

Junggu, South Korea

Gachon University Gil Medical Center

Namdong-gu, South Korea

Konyang University Hospital

Seogu, South Korea

Konyang University Hospital

Seogu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

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

Seoul, South Korea

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

Uijeongbu-si, South Korea

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Taipei City Hospital - Songde Branch

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

Layton Medical Centre

Blackpool, United Kingdom

St Pancras Clinical Research - Chester

Chester, United Kingdom

St Pancras Clinical Research - Eastbourne

Eastbourne, United Kingdom

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

St Pancras Clinical Research

London, United Kingdom

National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)

London, United Kingdom

Clerkenwell Health - London - Baker Street

London, United Kingdom

Greater Manchester Mental Health NHS Foundation Trust

Manchester, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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