Alcohol Use DisorderPhase 3RENEW-ALC-2NCT07219953
A Study of Brenipatide in Participants With Alcohol Use Disorder
A Phase 3 study testing LY3537031 in people with Alcohol Use Disorder, run by Eli Lilly and Company at 116 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- LY3537031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 116 sitesin 8 countries
- Study dates
- 16 Oct 2025to Apr 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
116 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
116 sites in 8 countries
United States29 sites, 1 recruiting
- Active, not recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, 21229
- Active, not recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
- Active, not recruiting
Re:Cognition Health - Chicago
Chicago, Illinois, 60611
- Active, not recruiting
Modern Research Associates, PLLC
Dallas, Texas, 75231
- Active, not recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
- Active, not recruiting
Re:Cognition Health
Fairfax, Virginia, 22031
- Active, not recruiting
K2 Medical Research - Foxborough
Foxborough, Massachusetts, 02035
- Active, not recruiting
Biopharma Informatic, LLC
Houston, Texas, 77043
- Active, not recruiting
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803
- Active, not recruiting
Innovative Clinical Research
Lauderhill, Florida, 33319
- Active, not recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
- Active, not recruiting
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, 90095
- Active, not recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751
- Active, not recruiting
K2 Medical Research ORLANDO
Maitland, Florida, 32751
- Active, not recruiting
Life Arc Research Centers - Miami
Miami, Florida, 33126
- Active, not recruiting
Wellness Research Center
Miami, Florida, 33135
- Active, not recruiting
Life Medical Research Group Corp
Miami Gardens, Florida, 33014
- Recruiting
North Star Medical Research
Middleburg Heights, Ohio, 44130
Mark Woyshville
- Active, not recruiting
Charter Research - Orlando
Orlando, Florida, 32803
- Active, not recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
- Active, not recruiting
Brown University School of Public Health
Providence, Rhode Island, 02903
- Active, not recruiting
Artemis Institute for Clinical Research
Riverside, California, 92503
- Active, not recruiting
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, 20853
- Active, not recruiting
Artemis Institute for Clinical Research
San Diego, California, 92123
- Active, not recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, 94158
- Active, not recruiting
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
- Active, not recruiting
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108
- Active, not recruiting
K2 Medical Research - Tampa
Tampa, Florida, 33634
- Active, not recruiting
Adams Clinical Bronx
The Bronx, New York, 10461
China27 sites, 27 recruiting
- Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
Xiaomeng Xing
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, 100096
Yunlong Tan
- Recruiting
The Second People's Hospital of Hunan Province
Changsha, 410007
Xuhui Zhou
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, 410011
Wei Hao
- Recruiting
West China Hospital, Sichuan University
Cheng Du Shi, 610041
18980601715
Jing Li
- Recruiting
The Fourth People's Hospital of Chengdu
Chengdu, 610036
+86 13458529130
Xi Tan
- Recruiting
Guangzhou Brain Hospital
Guangzhou, 510370
Ni Fan
- Recruiting
The Seventh People's Hospital of Hangzhou
Hangzhou, 310000
86-0571-85127129
Wanjun Guo
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Zhengluan Liao
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310016
Jinsong Tang
- Recruiting
The Fourth Hospital of Harbin Medical University
Harbin, 150001
Leijing Zhang
- Recruiting
Hefei No.4 People's Hospital
Hefei, 230061
Liangjun Pang
- Recruiting
Huzhou Third Municipal Hospital
Huzhou, 313000
Mincai Qian
- Recruiting
Shandong Mental Health Center
Jinan, 250012
Wei Yuan
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, 650032
Jin Lu
- Recruiting
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201
Haihang Yu
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Jiang Du
- Recruiting
Shenzhen Kangning Hospital
Shenzhen, 518003
Mei Yang
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
Qifeng Zhu
- Recruiting
The Affiliated hospital of Southwest Medical University
Sichuan, 646000
Kezhi Liu
- Recruiting
Wuhu Hospital of Beijing Anding hospital
Wuhu, 242407
Changqing Hu
- Recruiting
Xi An Mental Health Center
Xi'an, 710061
Guibin Li
- Recruiting
Xiamen Xianyue Hospital
Xiamen, 361012
Yan Qiu
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
13572769709
Aihong Guo
- Recruiting
Psychiatric Hospital of Henan Province
Xinxiang, 453003
Dan Wang
- Recruiting
Zhenjiang Mental Health Center
Zhenjiang, 212000
13952852603
Zhoubing Wang
- Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, 463000
Chong Wang
Japan16 sites, 16 recruiting
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Ai Sakura Clinic
Fukuoka, 810-0001
81120023812
Masamiki Kimura
- Recruiting
Hiro Mental Clinic
Fukuoka, 810-0004
81120023812
Hiroaki Furui
- Recruiting
Rainbow and Sea Hospital
Karatsu, 847-0031
81120023812
Taro Shindo
- Recruiting
Tatsuta Clinic
Kobe, 651-0097
81120023812
Kenji Tatsuta
- Recruiting
Arata Clinic
Nagasaki, 852-8137
81120023812
Takatoshi Mori
- Recruiting
Noguchi Naika Clinic
Nakano, 165-0031
81120023812
Yoshimasa Noguchi
- Recruiting
Yokogawa Ekimae Clinic
Nishi, 733-0011
81120023812
Ariyuki Kagaya
- Recruiting
Hillside Clinic Jingumae
Shibuya City, 150-0001
81120023812
Masayoshi SONE
- Recruiting
Samoncho Clinic
Shinjuku, 160-0017
81120023812
Takahiro Yokoyama
- Recruiting
Keiai Clinic
Shinjuku-ku, 160-0004
81120023812
Yoshinori Horie
- Recruiting
Higashi Shinjuku Clinic
Shinjuku-ku, 169-0072
81120023812
Hiroaki Kondo
- Recruiting
Sakurazaka Clinic SophyAnce
Tokyo, 106-0032
81120023812
Haruhito Muto
- Recruiting
Tsukuba University Hospital
Tsukuba, 305-8576
81120023812
Hisashi Yoshimoto
- Recruiting
Maekawa Medical Clinic
Yokohama, 220-0004
81120023812
Hiromitsu Maekawa
- Recruiting
National Hospital Organization Hizen Psychiatric Medical Center
Yoshinogari-cho, Kanzaki-gun, 842-0192
81120023812
Kazunori Matsuguchi
South Korea15 sites, 15 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, 14068
Kyung Hee Park
- Recruiting
Pusan National University Yangsan Hospital
Busan, 50612
82-55-360-2860
Sang Yeoup Lee
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
Joon Hyung Jung
- Recruiting
Hanyang University Guri Hospital
Guri-si, 11923
Sangmo Hong
- Recruiting
Inha University Hospital
Incheon, 22332
Yangsik Kim
- Recruiting
Kyungpook National University Hospital
Junggu, 41944
Hae-Jin Ko
- Recruiting
Gachon University Gil Medical Center
Namdong-gu, 21565
+82-32-458-2778
Kyoung-Kon Kim
- Recruiting
Konyang University Hospital
Seogu, 35365
Jee Hyun Kang
- Recruiting
Konyang University Hospital
Seogu, 35365
Hong Seok Oh
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Kiheon Lee
- Recruiting
Seoul National University Hospital
Seoul, 03080
BeLong Cho
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Byung Wan Lee
- Recruiting
Hanyang University Seoul Hospital
Seoul, 04763
Sungwon Roh
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Daijin Kim
- Recruiting
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
Hae Kook Lee
United Kingdom11 sites, 11 recruiting
- Recruiting
Layton Medical Centre
Blackpool, FY3 7EN
441253951943
Rebecca Clark
- Recruiting
Clerkenwell Health - Doncaster
Doncaster, DN4 8QN
Ibreez Ajaz
- Recruiting
St Pancras Clinical Research - Eastbourne
Eastbourne, BN23 5UZ
02038651142
Ward Lawrence
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
(+44) 0141 232 7600
Nagore Penades
- Recruiting
Mounts Bay Medical Hub
Hayle, TR27 5DT
Richard Burkimsher
- Recruiting
HMC Health Group - Meadows Centre for Health
Hounslow, TW4 7NR
07946732168
Ivor Singh
- Recruiting
St Pancras Clinical Research
London, EC2Y 8EA
020 3865 1142
Graham Campbell
- Recruiting
Clerkenwell Health - London - Baker Street
London, W1U 6RP
Alishah Suleman
- Recruiting
Newquay Health Centre
Newquay, TR7 1RU
01637 850002
Nicholas Jacobsen
- Recruiting
Panthera Biopartners - Preston
Preston, PR2 9QB
01772237822
Samin Chowdhury
- Recruiting
Wickersley Health Centre - Clifton Medical Centre
Rotherham, S65 1DA
01709363950
Matthew Capehorn
Germany7 sites, 7 recruiting
- Recruiting
FutureMeds Berlin
Berlin, 10629
+49 30 439741 239
Peter Hahn
- Recruiting
Velocity Clinical Research, Berlin
Berlin, 10787
493020859400
Isabelle Schenkenberger
- Recruiting
Klinische Forschung Dresden
Dresden, 01069
00493512052780
Peter Heymer
- Recruiting
Klinische Forschung Hamburg
Hamburg, 20253
49404607630
Christian Deckert
- Recruiting
Zentralinstitut für Seelische Gesundheit
Mannheim, 68159
00496211703-3888
Patrick Bach
- Recruiting
FutureMeds Offenbach
Offenbach, 63065
004969 247 433 840
Florieke Berfelo
- Recruiting
Klinische forschung Schwerin GmbH
Schwerin, 19055
0049385557740
Christine Paschen
Taiwan6 sites, 5 recruiting
- Recruiting
Changhua Christian Hospital
Changhua County, 50006
Hsu Wen-Yu
- Recruiting
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, 970
Shao-Tsu Chen
- Recruiting
China Medical University Hospital
Taichung, 404332
Wan-Ju Cheng
- Recruiting
Mackay Memorial Hospital
Taipei, 10449
Chen-Ju Lin
- Recruiting
Tri-Service General Hospital
Taipei, 114
San-Yuan Huang
- Active, not recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Belgium5 sites, 5 recruiting
- Recruiting
ANIMA Research
Diepenbeek, 3590
003211316272
Erik Buntinx
- Recruiting
Kormont
Kluisbergen, 9690
32 496 376259
Klaas Vercruysse
- Recruiting
Gezondheidshuis De Gloed
Machelen, 9870
32 496 376259
Klaas Vercruysse
- Recruiting
Meclinas
Mechelen, 2800
003215792797
Claudia Cornelis
- Recruiting
Medisch Centrum Saffrou
Oudenaarde, 9636
32 496 376259
Klaas Vercruysse
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- LY3537031, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537031Drug
Also called Brenipatide
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3537031 Period 1 | Experimental | Escalating doses administered subcutaneously (SC) Receives: Drug: LY3537031; Drug: Placebo |
| LY3537031 Period 2 | Experimental | Administered SC Receives: Drug: LY3537031; Drug: Placebo |
| Placebo | Placebo comparator | Administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Measured: Up to 56 weeks
Secondary outcomes (7)
Change in Daily Alcohol Consumption as Assessed by the TLFB
Measured: Up to 56 weeks
Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)
Measured: Baseline up to Week 56
Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Measured: Baseline up to Week 56
Mean Change in Body Weight
Measured: 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
Measured: Baseline up to Week 56
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline up to Week 56
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Measured: Baseline up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start16 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219953
- Sponsor's protocol ID
- 27410
- Other IDs
- 2025-522312-16-00, J2S-MC-GZMP, 2025
- Acronym
- RENEW-ALC-2
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.