A Study of Brenipatide in Participants With Alcohol Use Disorder (RENEW-ALC-2)

June 2, 2026 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Diepenbeek, Belgium, 3590
        • Recruiting
        • ANIMA Research
        • Principal Investigator:
          • Erik Buntinx
        • Contact:
          • Phone Number: 003211316272
      • Kluisbergen, Belgium, 9690
        • Recruiting
        • Kormont
        • Principal Investigator:
          • Klaas Vercruysse
        • Contact:
          • Phone Number: 32 496 376259
      • Machelen, Belgium, 9870
        • Recruiting
        • Gezondheidshuis De Gloed
        • Principal Investigator:
          • Klaas Vercruysse
        • Contact:
          • Phone Number: 32 496 376259
      • Mechelen, Belgium, 2800
        • Recruiting
        • Meclinas
        • Principal Investigator:
          • Claudia Cornelis
        • Contact:
          • Phone Number: 003215792797
      • Oudenaarde, Belgium, 9636
        • Recruiting
        • Medisch Centrum Saffrou
        • Principal Investigator:
          • Klaas Vercruysse
        • Contact:
          • Phone Number: 32 496 376259
  • China
      • Beijing, China, 100096
        • Recruiting
        • Beijing HuiLongGuan Hospital
        • Principal Investigator:
          • Yunlong Tan
      • Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital - Affiliated Capital University of Medical Science
        • Principal Investigator:
          • Xiaomeng Xing
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Wei Hao
      • Changsha, China, 410007
        • Recruiting
        • The Second People's Hospital of Hunan Province
        • Principal Investigator:
          • Xuhui Zhou
      • Cheng Du Shi, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Jing Li
        • Contact:
          • Phone Number: 18980601715
      • Chengdu, China, 610036
        • Recruiting
        • The Fourth People's Hospital of Chengdu
        • Contact:
          • Phone Number: +86 13458529130
        • Principal Investigator:
          • Xi Tan
      • Guangzhou, China, 510370
        • Recruiting
        • Guangzhou Brain Hospital
        • Principal Investigator:
          • Ni Fan
      • Hangzhou, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Principal Investigator:
          • Zhengluan Liao
      • Hangzhou, China, 310000
        • Recruiting
        • The Seventh People's Hospital of Hangzhou
        • Contact:
          • Phone Number: 86-0571-85127129
        • Principal Investigator:
          • Wanjun Guo
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Jinsong Tang
      • Harbin, China, 150001
        • Recruiting
        • The Fourth Hospital of Harbin Medical University
        • Principal Investigator:
          • Leijing Zhang
      • Hefei, China, 230061
        • Recruiting
        • Hefei No.4 People's Hospital
        • Principal Investigator:
          • Liangjun Pang
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Third Municipal Hospital
        • Principal Investigator:
          • Mincai Qian
      • Jinan, China, 250012
        • Recruiting
        • Shandong Mental Health Center
        • Principal Investigator:
          • Wei Yuan
      • Kunming, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Jin Lu
      • Ningbo, China, 315201
        • Recruiting
        • The Affilicated Kangning Hospital of Ningbo University
        • Principal Investigator:
          • Haihang Yu
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Principal Investigator:
          • Jiang Du
      • Shenzhen, China, 518003
        • Recruiting
        • Shenzhen Kangning Hospital
        • Principal Investigator:
          • Mei Yang
      • Shijiazhuang, China, 050031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Principal Investigator:
          • Qifeng Zhu
      • Sichuan, China, 646000
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Principal Investigator:
          • Kezhi Liu
      • Wuhu, China, 242407
        • Recruiting
        • Wuhu Hospital of Beijing Anding hospital
        • Principal Investigator:
          • Changqing Hu
      • Xi'an, China, 710061
        • Recruiting
        • Xi An Mental Health Center
        • Principal Investigator:
          • Guibin Li
      • Xiamen, China, 361012
        • Recruiting
        • Xiamen Xianyue Hospital
        • Principal Investigator:
          • Yan Qiu
      • Xianyang, China, 712000
        • Recruiting
        • Xianyang Hospital of Yan'an University
        • Contact:
          • Phone Number: 13572769709
        • Principal Investigator:
          • Aihong Guo
      • Xinxiang, China, 453003
        • Recruiting
        • Psychiatric Hospital of Henan Province
        • Principal Investigator:
          • Dan Wang
      • Zhenjiang, China, 212000
        • Recruiting
        • Zhenjiang Mental Health Center
        • Contact:
          • Phone Number: 13952852603
        • Principal Investigator:
          • Zhoubing Wang
      • Zhumadian, China, 463000
        • Recruiting
        • Zhumadian Psychiatric Hospital
        • Principal Investigator:
          • Chong Wang
  • Germany
      • Berlin, Germany, 10629
        • Recruiting
        • FutureMeds GmbH
        • Principal Investigator:
          • Peter Hahn
        • Contact:
          • Phone Number: +49 30 439741 239
      • Berlin, Germany, 10787
        • Recruiting
        • Velocity Clinical Research, Berlin
        • Principal Investigator:
          • Isabelle Schenkenberger
        • Contact:
          • Phone Number: 493020859400
      • Dresden, Germany, 01069
        • Recruiting
        • Klinische Forschung Dresden
        • Principal Investigator:
          • Peter Heymer
        • Contact:
          • Phone Number: 00493512052780
      • Hamburg, Germany, 20253
        • Recruiting
        • Klinische Forschung Hamburg
        • Contact:
          • Phone Number: 49404607630
        • Principal Investigator:
          • Christian Deckert
      • Mannheim, Germany, 68159
        • Recruiting
        • Zentralinstitut für Seelische Gesundheit
        • Contact:
          • Phone Number: 00496211703-3888
        • Principal Investigator:
          • Patrick Bach
      • Offenbach, Germany, 63065
        • Recruiting
        • Dedicated Research Site FutureMeds
        • Contact:
          • Phone Number: 004969 247 433 840
        • Principal Investigator:
          • Florieke Berfelo
      • Schwerin, Germany, 19055
        • Recruiting
        • Klinische Forschung Schwerin GmbH
        • Principal Investigator:
          • Christine Paschen
        • Contact:
          • Phone Number: 0049385557740
  • Japan
      • Ashiya, Japan, 659-0093
        • Not yet recruiting
        • Takahashi Psychiatric Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • MICHIHIRO TAKAHASHI
      • Chūōku, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Fukuoka, Japan, 810-0001
        • Recruiting
        • Ai Sakura Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masamiki Kimura
      • Fukuoka, Japan, 810-0004
        • Recruiting
        • Hiro Mental Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Furui
      • Karatsu, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Taro Shindo
      • Kobe, Japan, 651-0097
        • Recruiting
        • Tatsuta Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenji Tatsuta
      • Nagasaki, Japan, 852-8137
        • Recruiting
        • Arata Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takatoshi Mori
      • Nishi, Japan, 733-0011
        • Recruiting
        • Yokogawa Ekimae Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ariyuki Kagaya
      • Sapporo, Japan, 006-0811
        • Not yet recruiting
        • Teine Keijinkai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomohiro Shirasaka
      • Shibuya City, Japan, 150-0001
        • Recruiting
        • Hillside Clinic Jingumae
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masayoshi SONE
      • Shinjuku, Japan, 160-0017
        • Recruiting
        • Samoncho Clinic
        • Principal Investigator:
          • takahiro yokoyama
        • Contact:
          • Phone Number: 81120023812
      • Shinjuku-ku, Japan, 169-0072
        • Recruiting
        • Higashi Shinjuku Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Kondo
      • Shinjuku-ku, Japan, 160-0004
        • Recruiting
        • Keiai Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshinori Horie
      • Tokyo, Japan, 106-0032
        • Recruiting
        • Sakurazaka Clinic SophyAnce
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Haruhito Muto
      • Tokyo, Japan, 165-0031
        • Recruiting
        • Noguchi Naika Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshimasa Noguchi
      • Tsukuba, Japan, 305-8576
        • Recruiting
        • Tsukuba University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisashi Yoshimoto
      • Yokohama, Japan, 231-0032
        • Not yet recruiting
        • Makoto Kokoro No Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koichi Yamada
      • Yokohama, Japan, 220-0004
        • Recruiting
        • Maekawa Medical Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiromitsu Maekawa
      • Yoshinogari-cho, Kanzaki-gun, Japan, 842-0192
        • Recruiting
        • National Hospital Organization Hizen Psychiatric Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazunori Matsuguchi
  • South Korea
      • Anyang-si, South Korea, 14068
        • Not yet recruiting
        • Hallym University Sacred Heart Hospital
        • Principal Investigator:
          • Kyung Hee Park
      • Busan, South Korea, 50612
        • Not yet recruiting
        • Pusan National University Yangsan Hospital
        • Principal Investigator:
          • Sang Yeoup Lee
        • Contact:
          • Phone Number: 82-55-360-2860
      • Cheongju-si, South Korea, 28644
        • Not yet recruiting
        • Chungbuk National University Hospital
        • Principal Investigator:
          • Joon Hyung Jung
      • Guri-si, South Korea, 11923
        • Not yet recruiting
        • Hanyang University Guri Hospital
        • Principal Investigator:
          • Sangmo Hong
      • Incheon, South Korea, 22332
        • Not yet recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Yangsik Kim
      • Junggu, South Korea, 41944
        • Not yet recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Hae-Jin Ko
      • Namdong-gu, South Korea, 21565
        • Not yet recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Kyoung-Kon Kim
        • Contact:
          • Phone Number: +82-32-458-2778
      • Seogu, South Korea, 35365
        • Not yet recruiting
        • Konyang University Hospital
        • Principal Investigator:
          • Hong Seok Oh
      • Seongnam, South Korea, 13620
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Kiheon Lee
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • BeLong Cho
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Byung Wan Lee
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Principal Investigator:
          • Daijin Kim
      • Seoul, South Korea, 04763
        • Not yet recruiting
        • Hanyang University Seoul Hospital
        • Principal Investigator:
          • Sungwon Roh
      • Uijeongbu-si, South Korea, 11765
        • Not yet recruiting
        • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
        • Principal Investigator:
          • Hae Kook Lee
  • Taiwan
      • Changhua County, Taiwan, 50006
        • Not yet recruiting
        • Changhua Christian Hospital
        • Principal Investigator:
          • Hsu Wen-Yu
      • Hualien City, Taiwan, 970
        • Not yet recruiting
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Principal Investigator:
          • Shao-Tsu Chen
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Wan-Ju Cheng
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • Chen-Ju Lin
      • Taipei, Taiwan, 114
        • Not yet recruiting
        • Tri-Service General Hospital
        • Principal Investigator:
          • San-Yuan Huang
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Huang-Li Lin
  • United Kingdom
      • Blackpool, United Kingdom, FY3 7EN
        • Recruiting
        • Layton Medical Centre
        • Contact:
          • Phone Number: 441253951943
        • Principal Investigator:
          • Rebecca Clark
      • Doncaster, United Kingdom, DN4 8QN
        • Not yet recruiting
        • Clerkenwell Health - Doncaster
        • Principal Investigator:
          • Ivelin Trifonov
        • Contact:
          • Phone Number: 01302245049
      • Eastbourne, United Kingdom, BN23 5UZ
        • Not yet recruiting
        • St Pancras Clinical Research - Eastbourne
        • Contact:
          • Phone Number: 02038651142
        • Principal Investigator:
          • Ward Lawrence
      • Glasgow, United Kingdom, G51 4TF
        • Recruiting
        • Queen Elizabeth University Hospital
        • Contact:
          • Phone Number: (+44) 0141 232 7600
        • Principal Investigator:
          • Nagore Penades
      • Hayle, United Kingdom, TR27 5DT
        • Recruiting
        • Mounts Bay Medical Hub
        • Principal Investigator:
          • Richard Burkimsher
      • Hounslow, United Kingdom, TW4 7NR
        • Recruiting
        • HMC Health Group - Meadows Centre for Health
        • Principal Investigator:
          • Ivor Singh
        • Contact:
          • Phone Number: 07946732168
      • London, United Kingdom, EC2Y 8EA
        • Not yet recruiting
        • St Pancras Clinical Research
        • Contact:
          • Phone Number: 020 3865 1142
        • Principal Investigator:
          • Graham Campbell
      • London, United Kingdom, W1U 6RP
        • Recruiting
        • Clerkenwell Health - London - Baker Street
        • Principal Investigator:
          • Alishah Suleman
      • Newquay, United Kingdom, TR7 1RU
        • Recruiting
        • Newquay Health Centre
        • Principal Investigator:
          • Nicholas Jacobsen
        • Contact:
          • Phone Number: 01637 850002
      • Preston, United Kingdom, PR2 9QB
        • Recruiting
        • Panthera Biopartners - Preston
        • Contact:
          • Phone Number: 01772237822
        • Principal Investigator:
          • Samin Chowdhury
      • Rotherham, United Kingdom, S65 1DA
        • Recruiting
        • Wickersley Health Centre - Clifton Medical Centre
        • Contact:
          • Phone Number: 01709363950
        • Principal Investigator:
          • Matthew Capehorn
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Headlands Research - Scottsdale
        • Principal Investigator:
          • Rosika McKinney
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
        • Contact:
          • Phone Number: 501-221-8681
        • Principal Investigator:
          • George Konis
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Clinical & Translational Research Center (CTRC)
        • Contact:
          • Phone Number: 310-794-5383
        • Principal Investigator:
          • Lara Ray
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 951-374-1190
        • Principal Investigator:
          • Jack Vu
      • San Diego, California, United States, 92123
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 858-278-3647
        • Principal Investigator:
          • Eric Chavez
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
        • Principal Investigator:
          • Khaled Moussawi
    • Florida
      • Lakeland, Florida, United States, 33803
        • Recruiting
        • Accel Research Sites - Lakeland Clinical Research Unit
        • Contact:
          • Phone Number: 863-940-2087
        • Principal Investigator:
          • James Andersen
      • Lauderhill, Florida, United States, 33319
        • Not yet recruiting
        • Innovative Clinical Research
        • Principal Investigator:
          • Rishi Kakar
        • Contact:
          • Phone Number: 786-570-1971
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research - Maitland
        • Principal Investigator:
          • Sejal Patel
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Brandon Lenox
      • Miami, Florida, United States, 33135
        • Recruiting
        • Wellness Research Center
        • Contact:
          • Phone Number: 305-300-2623
        • Principal Investigator:
          • Emilio Mantero-Atienza
      • Miami, Florida, United States, 33126
        • Recruiting
        • Life Arc Research Centers - Miami
        • Contact:
          • Phone Number: 305-874-7401
        • Principal Investigator:
          • Damian Casadesus
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • Life Medical Research Group Corp
        • Contact:
          • Phone Number: 305-705-4111
        • Principal Investigator:
          • Rafael Conte
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Orlando
        • Principal Investigator:
          • Jorel Martinez
      • Tampa, Florida, United States, 33634
        • Recruiting
        • K2 Medical Research - Tampa
        • Contact:
          • Phone Number: 813-800-5252
        • Principal Investigator:
          • Kelley Wilson
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Re:Cognition Health - Chicago
        • Principal Investigator:
          • Abid Nazeer
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Recruiting
        • Maryland Treatment Centers - Mountain Manor Treatment Center
        • Principal Investigator:
          • Marc Fishman
      • Rockville, Maryland, United States, 20853
        • Recruiting
        • Maryland Treatment Centers - Avery Road Treatment Center
        • Principal Investigator:
          • Marc Fishman
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Recruiting
        • Adams Clinical Boston
        • Principal Investigator:
          • Darin Dougherty
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • K2 Medical Research - Foxborough
        • Contact:
          • Phone Number: 401-435-8950
        • Principal Investigator:
          • john stoukides
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Adams Clinical Bronx
        • Principal Investigator:
          • Shama Farooq
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • North Star Medical Research
        • Principal Investigator:
          • Mark Woyshville
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine: University of Pennsylvania Health System
        • Contact:
          • Phone Number: 215-746-1943
        • Principal Investigator:
          • Henry Kranzler
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Brown University School of Public Health
        • Principal Investigator:
          • Carolina Haass-Koffler
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Avera Research Institute - Sioux Falls
        • Contact:
          • Phone Number: 605-504-3154
        • Principal Investigator:
          • Vivek Anand
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Modern Research Associates, PLLC
        • Principal Investigator:
          • JOHN CATHER
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Adams Clinical Dallas
        • Principal Investigator:
          • Benji Kurian
      • Houston, Texas, United States, 77043
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Agadadash Kuliev
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Re:Cognition Health
        • Principal Investigator:
          • Scott Williams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administered SC
Drug: Placebo
Administered SC
Experimental: LY3537031 Period 1
Escalating doses administered subcutaneously (SC)
Drug: Placebo
Administered SC
Drug: LY3537031
Administered SC
Other Names:
  • Brenipatide
Experimental: LY3537031 Period 2
Administered SC
Drug: Placebo
Administered SC
Drug: LY3537031
Administered SC
Other Names:
  • Brenipatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Time Frame: Up to 56 weeks
Up to 56 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Daily Alcohol Consumption as Assessed by the TLFB
Time Frame: Up to 56 weeks
Up to 56 weeks
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Time Frame: Baseline up to Week 56
Baseline up to Week 56
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Time Frame: Baseline up to Week 56
Baseline up to Week 56
Mean Change in Body Weight
Time Frame: Baseline up to Week 56
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
Time Frame: Baseline up to Week 56
Baseline up to Week 56
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time Frame: Baseline up to Week 56
Baseline up to Week 56
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Time Frame: Baseline up to Week 56
Baseline up to Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

October 13, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Actual)

October 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27410
  • 2025-522312-16-00 (Ctis)
  • J2S-MC-GZMP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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