A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
NCT ID: NCT07219966
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1100 participants
INTERVENTIONAL
2025-12-31
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3537031 Period 1
Escalating doses administered subcutaneously (SC)
LY3537031
Administered SC
Placebo
Administered SC
LY3537031 Period 2
Administered SC
LY3537031
Administered SC
Placebo
Administered SC
Placebo
Administered SC
Placebo
Administered SC
Interventions
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LY3537031
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging 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 unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 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
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
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
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
CIPREC
Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Mautalen Salud e Investigación
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Sanatorio Morra S.A.
Córdoba, , Argentina
Instituto Kremer
Córdoba, , Argentina
Centro Médico Luquez
Córdoba, , Argentina
Global Psy Asociación Civil
La Plata, , Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, , Argentina
Resolution Psychopharmacology Research Institute
Mendoza, , Argentina
Fundacion Estudios Clinicos
Rosario, , Argentina
Fundación Innovaciencia
Rosario, , Argentina
INECO Neurociencias Oroño
Rosario, , Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, , Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, , Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, , Argentina
Clinica El Jardin
Santiago del Estero, , Argentina
ANIMA Research
Alken, , 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
Shangdong 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
Keiai 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
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 District, , Taiwan
Charlton Lane
Cheltenham, , United Kingdom
Edinburgh Royal Infirmary
Edinburgh, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , 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
Salford Royal Hospital
Salford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Related Links
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A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
Other Identifiers
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2025-522313-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
JS2-MC-GZME
Identifier Type: OTHER
Identifier Source: secondary_id
27346
Identifier Type: -
Identifier Source: org_study_id