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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 115 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
115 sitesin 8 countries
Study dates
16 Oct 2025to Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

115 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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

115 sites in 8 countries

United States28 sites

  • 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

    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

    Active, not recruiting

Other trials in United States

China27 sites, 2 recruiting

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    Beijing, 100088

    Active, not recruiting

  • Beijing HuiLongGuan Hospital

    Beijing, 100096

    Yunlong Tan

    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

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014

    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

  • Hefei No.4 People's Hospital

    Hefei, 230061

    Active, not recruiting

  • Huzhou Third Municipal Hospital

    Huzhou, 313000

    Completed

  • Shandong Mental Health Center

    Jinan, 250012

    Active, not recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032

    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

  • The Affiliated hospital of Southwest Medical University

    Sichuan, 646000

    Active, not recruiting

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407

    Active, not recruiting

  • Xi An Mental Health Center

    Xi'an, 710061

    Guibin Li

    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

    Active, not recruiting

  • Zhumadian Psychiatric Hospital

    Zhumadian, 463000

    Active, not recruiting

Other trials in China

Japan16 sites, 16 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

    Recruiting

Other trials in Japan

South Korea15 sites, 15 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

    Recruiting

Other trials in South Korea

United Kingdom11 sites, 11 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

    Halah Almahdi

    Recruiting

  • Wickersley Health Centre - Clifton Medical Centre

    Rotherham, S65 1DA

    01709363950

    Matthew Capehorn

    Recruiting

Other trials in United Kingdom

Germany7 sites

  • 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

    Active, not recruiting

Other trials in Germany

Taiwan6 sites, 5 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

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Active, not recruiting

Other trials in Taiwan

Belgium5 sites, 5 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

    Recruiting

Other trials in Belgium

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.

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 groups in NCT07219953
Study groupRoleWhat they receive
LY3537031 Period 1ExperimentalEscalating doses administered subcutaneously (SC)
Receives: Drug: LY3537031; Drug: Placebo
LY3537031 Period 2ExperimentalAdministered SC
Receives: Drug: LY3537031; Drug: Placebo
PlaceboPlacebo comparatorAdministered SC
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Change in Daily Alcohol Consumption as Assessed by the TLFB

    Measured: Up to 56 weeks

  2. Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)

    Measured: Baseline up to Week 56

  3. Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score

    Measured: Baseline up to Week 56

  4. Mean Change in Body Weight

    Measured: Baseline up to Week 56

  5. 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

  6. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Measured: Baseline up to Week 56

  7. 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.

  1. First posted22 Oct 2025
  2. Study start16 Oct 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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)
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
Nov 2026
First submitted
13 Oct 2025
Last updated
4 Nov 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY3537031 in people with Alcohol Use Disorder, run by Eli Lilly and Company at 115 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, China, Japan, South Korea, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB) (time frame: Up to 56 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07219953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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