A Study of Brenipatide in Participants With Alcohol Use Disorder
RENEW-ALC-2
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 Alcohol Use Disorder (RENEW-ALC-2)
3 other identifiers
interventional
1,100
8 countries
114
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2025
CompletedStudy Start
First participant enrolled
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 17, 2026
April 1, 2026
2.5 years
October 13, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Up to 56 weeks
Secondary Outcomes (7)
Change in Daily Alcohol Consumption as Assessed by the TLFB
Up to 56 weeks
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Baseline up to Week 56
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Baseline up to Week 56
Mean Change in Body Weight
Baseline up to Week 56
Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores
Baseline up to Week 56
- +2 more secondary outcomes
Study Arms (3)
LY3537031 Period 1
EXPERIMENTALEscalating doses administered subcutaneously (SC)
LY3537031 Period 2
EXPERIMENTALAdministered SC
Placebo
PLACEBO COMPARATORAdministered SC
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
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
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
K2 Medical Research - East Providence
East Providence, Rhode Island, 02914, 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 District, 333, Taiwan
Layton Medical Centre
Blackpool, FY3 7EN, 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
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2025
First Posted
October 22, 2025
Study Start
October 16, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.