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New drug aims to curb alcohol cravings in major trial

NCT ID NCT07219966

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 9 times

Summary

This phase 3 study tests whether brenipatide can help adults with moderate-to-severe alcohol use disorder drink less and feel less urge to drink. About 1,100 motivated participants will receive either the drug or a placebo for 56 weeks. The main goal is to see changes in drinking patterns and cravings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brenipatide
What this could lead to
If it works, this could provide a new medication option to help people with alcohol use disorder reduce their drinking and cravings.
What could go wrong
This is a late-stage trial, but the drug may still fail to show meaningful benefit over placebo. Side effects or lack of long-term effectiveness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 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).

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    72 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ANIMA Research

    ACTIVE_NOT_RECRUITING

    Diepenbeek, 3590, Belgium

  • Accel Research Sites - Lakeland Clinical Research Unit

    RECRUITING

    Lakeland, Florida, 33803, United States

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Bronx

    RECRUITING

    The Bronx, New York, 10461, United States

  • Adams Clinical Dallas

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Ai Sakura Clinic

    ACTIVE_NOT_RECRUITING

    Fukuoka, 810-0001, Japan

  • Alpine Research Organization

    RECRUITING

    Clinton, Utah, 84015, United States

  • Arata Clinic

    ACTIVE_NOT_RECRUITING

    Nagasaki, 852-8137, Japan

  • Artemis Institute for Clinical Research

    RECRUITING

    San Diego, California, 92123, United States

  • Avera Research Institute - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    RECRUITING

    Beijing, 100088, China

  • Beijing HuiLongGuan Hospital

    RECRUITING

    Beijing, 100096, China

  • Chang Gung Medical Foundation-Linkou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • Charter Research - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • China Medical University Hospital

    RECRUITING

    Taichung, 404332, Taiwan

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, 28644, South Korea

  • Clerkenwell Health - London - Baker Street

    ACTIVE_NOT_RECRUITING

    London, W1U 6RP, United Kingdom

  • Dedicated Research Site FutureMeds

    ACTIVE_NOT_RECRUITING

    Offenbach, 63065, Germany

  • Edinburgh Royal Infirmary

    ACTIVE_NOT_RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, 650032, China

  • FutureMeds GmbH

    ACTIVE_NOT_RECRUITING

    Berlin, 10629, Germany

  • Gachon University Gil Medical Center

    RECRUITING

    Namdong-gu, 21565, South Korea

  • Gezondheidshuis De Gloed

    ACTIVE_NOT_RECRUITING

    Machelen, 9870, Belgium

  • Greater Manchester Mental Health NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Manchester, M25 3BL, United Kingdom

  • Guangzhou Brain Hospital

    RECRUITING

    Guangzhou, 510370, China

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang-si, 14068, South Korea

  • Hanyang University Guri Hospital

    RECRUITING

    Guri-si, 11923, South Korea

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, 04763, South Korea

  • Headlands Research - Scottsdale

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Higashi Shinjuku Clinic

    ACTIVE_NOT_RECRUITING

    Shinjuku-ku, 169-0072, Japan

  • Hillside Clinic Jingumae

    ACTIVE_NOT_RECRUITING

    Shibuya City, 150-0001, Japan

  • Hiro Mental Clinic

    ACTIVE_NOT_RECRUITING

    Fukuoka, 810-0004, Japan

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    RECRUITING

    Hualien City, 970, Taiwan

  • Huzhou Third Municipal Hospital

    RECRUITING

    Huzhou, 313000, China

  • K2 Medical Research - Foxborough

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • K2 Medical Research - Maitland

    RECRUITING

    Maitland, Florida, 32751, United States

  • K2 Medical Research - Tampa

    RECRUITING

    Tampa, Florida, 33634, United States

  • K2 Medical Research ORLANDO

    RECRUITING

    Maitland, Florida, 32751, United States

  • Kaedenomori Mental Clinic

    ACTIVE_NOT_RECRUITING

    Shibuya City, 150-0022, Japan

  • Kariya Hospital

    ACTIVE_NOT_RECRUITING

    Kariya, 448-0851, Japan

  • Keiai Clinic

    ACTIVE_NOT_RECRUITING

    Shinjuku-ku, 160-0004, Japan

  • Klinische Forschung Dresden

    ACTIVE_NOT_RECRUITING

    Dresden, 01069, Germany

  • Klinische Forschung Hamburg

    ACTIVE_NOT_RECRUITING

    Hamburg, 20253, Germany

  • Klinische forschung Schwerin GmbH

    ACTIVE_NOT_RECRUITING

    Schwerin, 19055, Germany

  • Konyang University Hospital

    ACTIVE_NOT_RECRUITING

    Seogu, 35365, South Korea

  • Kormont

    ACTIVE_NOT_RECRUITING

    Kluisbergen, 9690, Belgium

  • Kuramitsu Hospital

    ACTIVE_NOT_RECRUITING

    Fukuoka, 819-0037, Japan

  • Kyungpook National University Hospital

    RECRUITING

    Junggu, 41944, South Korea

  • Layton Medical Centre

    ACTIVE_NOT_RECRUITING

    Blackpool, FY3 7EN, United Kingdom

  • Life Arc Research Centers - Miami

    RECRUITING

    Miami, Florida, 33126, United States

  • Life Medical Research Group Corp

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Mackay Memorial Hospital

    RECRUITING

    Taipei, 10449, Taiwan

  • Maekawa Medical Clinic

    ACTIVE_NOT_RECRUITING

    Yokohama, 220-0004, Japan

  • Maryland Treatment Centers - Avery Road Treatment Center

    RECRUITING

    Rockville, Maryland, 20853, United States

  • Maryland Treatment Centers - Mountain Manor Treatment Center

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Meclinas

    ACTIVE_NOT_RECRUITING

    Mechelen, 2800, Belgium

  • Medisch Centrum Saffrou

    ACTIVE_NOT_RECRUITING

    Oudenaarde, 9636, Belgium

  • Mountain Mind - Denver

    RECRUITING

    Denver, Colorado, 80202, United States

  • National Hospital Organization Hizen Psychiatric Medical Center

    ACTIVE_NOT_RECRUITING

    Yoshinogari-cho, Kanzaki-gun, 842-0192, Japan

  • National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)

    ACTIVE_NOT_RECRUITING

    London, SE5 9RS, United Kingdom

  • Noguchi Naika Clinic

    ACTIVE_NOT_RECRUITING

    Tokyo, 165-0031, Japan

  • North Star Medical Research

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Parkway Medical Center

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35215, United States

  • Penn Medicine: University of Pennsylvania Health System

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Pillar Clinical Research - Richardson

    RECRUITING

    Richardson, Texas, 75080, United States

  • Psychiatric Hospital of Henan Province

    RECRUITING

    Xinxiang, 453003, China

  • Pusan National University Yangsan Hospital

    ACTIVE_NOT_RECRUITING

    Busan, 50612, South Korea

  • Queen Elizabeth University Hospital

    ACTIVE_NOT_RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Rainbow and Sea Hospital

    ACTIVE_NOT_RECRUITING

    Karatsu, 847-0031, Japan

  • Re:Cognition Health

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Re:Cognition Health - Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Sakurazaka Clinic SophyAnce

    ACTIVE_NOT_RECRUITING

    Tokyo, 106-0032, Japan

  • Samoncho Clinic

    ACTIVE_NOT_RECRUITING

    Shinjuku, 160-0017, Japan

  • Sangenjaya Shinkeika Shinryonaika Clinic

    ACTIVE_NOT_RECRUITING

    Setagaya City, 154-0004, Japan

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shandong Mental Health Center

    ACTIVE_NOT_RECRUITING

    Jinan, 250012, China

  • Shanghai Mental Health Center

    RECRUITING

    Shanghai, 200030, China

  • Shenzhen Kangning Hospital

    RECRUITING

    Shenzhen, 518003, China

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • Southampton General Hospital

    ACTIVE_NOT_RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • St Pancras Clinical Research

    ACTIVE_NOT_RECRUITING

    London, EC2Y 8EA, United Kingdom

  • St Pancras Clinical Research - Chester

    ACTIVE_NOT_RECRUITING

    Chester, CH2 1HX, United Kingdom

  • St Pancras Clinical Research - Eastbourne

    ACTIVE_NOT_RECRUITING

    Eastbourne, BN23 5UZ, United Kingdom

  • Taipei City Hospital - Songde Branch

    RECRUITING

    Taipei, 110204, Taiwan

  • Tatsuta Clinic

    ACTIVE_NOT_RECRUITING

    Kobe, 651-0097, Japan

  • The Affiliated hospital of Southwest Medical University

    RECRUITING

    Luzhou, 646000, China

  • The Affilicated Kangning Hospital of Ningbo University

    RECRUITING

    Ningbo, 315201, China

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 06591, South Korea

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    RECRUITING

    Uijeongbu-si, 11765, South Korea

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, 330006, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050031, China

  • The Fourth Hospital of Harbin Medical University

    RECRUITING

    Harbin, 150001, China

  • The Fourth People's Hospital of Chengdu

    RECRUITING

    Chengdu, 610036, China

  • The Second People's Hospital of Hunan Province

    RECRUITING

    Changsha, 410007, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, 410011, China

  • The Seventh People's Hospital of Hangzhou

    RECRUITING

    Hangzhou, 310000, China

  • The Third Hospital of Mianyang

    RECRUITING

    Mianyang, 621000, China

  • Tianjin Anding Hospital

    RECRUITING

    Tianjin, 300022, China

  • Tokyo-Eki Center-building Clinic

    ACTIVE_NOT_RECRUITING

    Chūōku, 103-0027, Japan

  • Tri-Service General Hospital

    RECRUITING

    Taipei, 114, Taiwan

  • Tsukuba University Hospital

    ACTIVE_NOT_RECRUITING

    Tsukuba, 305-8576, Japan

  • UCLA Clinical & Translational Research Center (CTRC)

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center - Montlake

    RECRUITING

    Seattle, Washington, 98195, United States

  • Velocity Clinical Research, Berlin

    ACTIVE_NOT_RECRUITING

    Berlin, 10787, Germany

  • Wellness Research Center

    RECRUITING

    Miami, Florida, 33135, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Cheng Du Shi, 610041, China

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Wuhu Hospital of Beijing Anding hospital

    RECRUITING

    Wuhu, 242407, China

  • Xi An Mental Health Center

    RECRUITING

    Xi'an, 710061, China

  • Xiamen Xianyue Hospital

    RECRUITING

    Xiamen, 361012, China

  • Xianyang Hospital of Yan'an University

    RECRUITING

    Xianyang, 712000, China

  • Yokogawa Ekimae Clinic

    ACTIVE_NOT_RECRUITING

    Nishi, 733-0011, Japan

  • Zentralinstitut für Seelische Gesundheit

    ACTIVE_NOT_RECRUITING

    Mannheim, 68159, Germany

  • Zhenjiang Mental Health Center

    RECRUITING

    Zhenjiang, 212000, China

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