Alcohol Use DisorderPhase 3RENEW-ALC-1NCT07219966
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
A Phase 3 study testing LY3537031 in people with Alcohol Use Disorder, run by Eli Lilly and Company at 117 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 moderate-to-severe Alcohol Use Disorder (AUD). 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
- 117 sitesin 8 countries
- Study dates
- 15 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
- 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 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
117 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
117 sites in 8 countries
United States30 sites, 2 recruiting
- Active, not recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, 21229
- Completed
Parkway Medical Center
Birmingham, Alabama, 35215
- Active, not recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
- Active, not recruiting
Re:Cognition Health - Chicago
Chicago, Illinois, 60611
- Active, not recruiting
Alpine Research Organization
Clinton, Utah, 84015
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
214-645-6950
Sherwood Brown
- Active, not recruiting
Mountain Mind - Denver
Denver, Colorado, 80202
- 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
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, 33803
- Completed
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
- Completed
North Star Medical Research
Middleburg Heights, Ohio, 44130
- 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
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
- Recruiting
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, 20853
Marc Fishman
- 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
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
- 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
- Active, not recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
- Active, not recruiting
Beijing HuiLongGuan Hospital
Beijing, 100096
- Active, not recruiting
The Second People's Hospital of Hunan Province
Changsha, 410007
- Active, not recruiting
The Second Xiangya Hospital of Central South University
Changsha, 410011
- Active, not recruiting
West China Hospital, Sichuan University
Cheng Du Shi, 610041
- Active, not recruiting
The Fourth People's Hospital of Chengdu
Chengdu, 610036
- Active, not recruiting
Guangzhou Brain Hospital
Guangzhou, 510370
- Active, not recruiting
The Seventh People's Hospital of Hangzhou
Hangzhou, 310000
- Active, not recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310016
- Active, not recruiting
The Fourth Hospital of Harbin Medical University
Harbin, 150001
- Active, not recruiting
Huzhou Third Municipal Hospital
Huzhou, 313000
- Active, not recruiting
Shandong Mental Health Center
Jinan, 250012
- Active, not recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, 650032
- Active, not recruiting
The Affiliated hospital of Southwest Medical University
Luzhou, 646000
- Active, not recruiting
The Third Hospital of Mianyang
Mianyang, 621000
- Active, not recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
- Active, not recruiting
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201
- Active, not recruiting
Shanghai Mental Health Center
Shanghai, 200030
- Active, not recruiting
Shenzhen Kangning Hospital
Shenzhen, 518003
- Active, not recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
- Active, not recruiting
Tianjin Anding Hospital
Tianjin, 300022
- Active, not recruiting
Wuhu Hospital of Beijing Anding hospital
Wuhu, 242407
- Active, not recruiting
Xi An Mental Health Center
Xi'an, 710061
- Active, not recruiting
Xiamen Xianyue Hospital
Xiamen, 361012
- Active, not recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
- Active, not recruiting
Psychiatric Hospital of Henan Province
Xinxiang, 453003
- Active, not recruiting
Zhenjiang Mental Health Center
Zhenjiang, 212000
Japan20 sites
- Active, not recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
- Active, not recruiting
Ai Sakura Clinic
Fukuoka, 810-0001
- Active, not recruiting
Hiro Mental Clinic
Fukuoka, 810-0004
- Active, not recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
- Active, not recruiting
Rainbow and Sea Hospital
Karatsu, 847-0031
- Active, not recruiting
Kariya Hospital
Kariya, 448-0851
- Active, not recruiting
Tatsuta Clinic
Kobe, 651-0097
- Active, not recruiting
Arata Clinic
Nagasaki, 852-8137
- Active, not recruiting
Yokogawa Ekimae Clinic
Nishi, 733-0011
- Active, not recruiting
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, 154-0004
- Active, not recruiting
Hillside Clinic Jingumae
Shibuya City, 150-0001
- Active, not recruiting
Kaedenomori Mental Clinic
Shibuya City, 150-0022
- Active, not recruiting
Samoncho Clinic
Shinjuku, 160-0017
- Active, not recruiting
Keiai Clinic
Shinjuku-ku, 160-0004
- Active, not recruiting
Higashi Shinjuku Clinic
Shinjuku-ku, 169-0072
- Active, not recruiting
Sakurazaka Clinic SophyAnce
Tokyo, 106-0032
- Active, not recruiting
Noguchi Naika Clinic
Tokyo, 165-0031
- Active, not recruiting
Tsukuba University Hospital
Tsukuba, 305-8576
- Active, not recruiting
Maekawa Medical Clinic
Yokohama, 220-0004
- Active, not recruiting
National Hospital Organization Hizen Psychiatric Medical Center
Yoshinogari-cho, Kanzaki-gun, 842-0192
South Korea12 sites, 2 recruiting
- Active, not recruiting
Pusan National University Yangsan Hospital
Busan, 50612
- Active, not recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
- Active, not recruiting
Hanyang University Guri Hospital
Guri-si, 11923
- Active, not recruiting
Kyungpook National University Hospital
Junggu, 41944
- Active, not recruiting
Gachon University Gil Medical Center
Namdong-gu, 21565
- Active, not recruiting
Konyang University Hospital
Seogu, 35365
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Kiheon Lee
- Active, not recruiting
Seoul National University Hospital
Seoul, 03080
- Active, not recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Active, not recruiting
Hanyang University Seoul Hospital
Seoul, 04763
- Active, not recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
- Recruiting
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
Hae Kook Lee
United Kingdom10 sites
- Active, not recruiting
Layton Medical Centre
Blackpool, FY3 7EN
- Active, not recruiting
St Pancras Clinical Research - Chester
Chester, CH2 1HX
- Active, not recruiting
St Pancras Clinical Research - Eastbourne
Eastbourne, BN23 5UZ
- Active, not recruiting
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
- Active, not recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
- Active, not recruiting
St Pancras Clinical Research
London, EC2Y 8EA
- Active, not recruiting
National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)
London, SE5 9RS
- Active, not recruiting
Clerkenwell Health - London - Baker Street
London, W1U 6RP
- Active, not recruiting
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M25 3BL
- Active, not recruiting
Southampton General Hospital
Southampton, SO16 6YD
Germany7 sites
- Active, not recruiting
FutureMeds Berlin
Berlin, 10629
- Active, not recruiting
Velocity Clinical Research, Berlin
Berlin, 10787
- Active, not recruiting
Klinische Forschung Dresden
Dresden, 01069
- Active, not recruiting
Klinische Forschung Hamburg
Hamburg, 20253
- Active, not recruiting
Zentralinstitut für Seelische Gesundheit
Mannheim, 68159
- Active, not recruiting
FutureMeds Offenbach
Offenbach, 63065
- Active, not recruiting
Klinische forschung Schwerin GmbH
Schwerin, 19055
Taiwan6 sites
- Active, not recruiting
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, 970
- Active, not recruiting
China Medical University Hospital
Taichung, 404332
- Active, not recruiting
Mackay Memorial Hospital
Taipei, 10449
- Active, not recruiting
Taipei City Hospital - Songde Branch
Taipei, 110204
- Active, not recruiting
Tri-Service General Hospital
Taipei, 114
- Active, not recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Belgium5 sites
- Active, not recruiting
ANIMA Research
Diepenbeek, 3590
- Active, not recruiting
Kormont
Kluisbergen, 9690
- Active, not recruiting
Gezondheidshuis De Gloed
Machelen, 9870
- Active, not recruiting
Meclinas
Mechelen, 2800
- Active, not recruiting
Medisch Centrum Saffrou
Oudenaarde, 9636
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 Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
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.
- 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 start15 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
- NCT07219966
- Sponsor's protocol ID
- 27346
- Other IDs
- 2025-522313-38-00, J2S-MC-GZME, 2025
- Acronym
- RENEW-ALC-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2025
- Last updated
- 7 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.