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New shot could help heavy drinkers cut back

NCT ID NCT07219953

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 8 times

Summary

This study tests an experimental medicine called brenipatide to see if it helps adults with alcohol use disorder drink less and reduce cravings. About 1,100 participants will receive either the drug or a placebo by injection for nearly a year. The goal is to find a safe, effective treatment to help people control their drinking.

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 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 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    116 sites in 8 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

    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

    RECRUITING

    Fukuoka, 810-0001, Japan

  • Arata Clinic

    RECRUITING

    Nagasaki, 852-8137, Japan

  • Artemis Institute for Clinical Research

    RECRUITING

    Riverside, California, 92503, United States

  • 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

  • Biopharma Informatic, LLC

    RECRUITING

    Houston, Texas, 77043, United States

  • Brown University School of Public Health

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Chang Gung Medical Foundation-Linkou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • Changhua Christian Hospital

    RECRUITING

    Changhua County, 50006, 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 - Doncaster

    RECRUITING

    Doncaster, DN4 8QN, United Kingdom

  • Clerkenwell Health - London - Baker Street

    RECRUITING

    London, W1U 6RP, United Kingdom

  • Dedicated Research Site FutureMeds

    RECRUITING

    Offenbach, 63065, Germany

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, 650032, China

  • FutureMeds GmbH

    RECRUITING

    Berlin, 10629, Germany

  • Gachon University Gil Medical Center

    RECRUITING

    Namdong-gu, 21565, South Korea

  • Gezondheidshuis De Gloed

    RECRUITING

    Machelen, 9870, Belgium

  • Guangzhou Brain Hospital

    RECRUITING

    Guangzhou, 510370, China

  • HMC Health Group - Meadows Centre for Health

    RECRUITING

    Hounslow, TW4 7NR, United Kingdom

  • 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

  • Hefei No.4 People's Hospital

    RECRUITING

    Hefei, 230061, China

  • Higashi Shinjuku Clinic

    RECRUITING

    Shinjuku-ku, 169-0072, Japan

  • Hillside Clinic Jingumae

    RECRUITING

    Shibuya City, 150-0001, Japan

  • Hiro Mental Clinic

    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

  • Inha University Hospital

    RECRUITING

    Incheon, 22332, South Korea

  • Innovative Clinical Research

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • 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

  • Keiai Clinic

    RECRUITING

    Shinjuku-ku, 160-0004, Japan

  • Klinische Forschung Dresden

    RECRUITING

    Dresden, 01069, Germany

  • Klinische Forschung Hamburg

    RECRUITING

    Hamburg, 20253, Germany

  • Klinische forschung Schwerin GmbH

    RECRUITING

    Schwerin, 19055, Germany

  • Konyang University Hospital

    RECRUITING

    Seogu, 35365, South Korea

  • Konyang University Hospital

    RECRUITING

    Seogu, 35365, South Korea

  • Kormont

    RECRUITING

    Kluisbergen, 9690, Belgium

  • Kyungpook National University Hospital

    RECRUITING

    Junggu, 41944, South Korea

  • Layton Medical Centre

    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

    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

    RECRUITING

    Mechelen, 2800, Belgium

  • Medisch Centrum Saffrou

    RECRUITING

    Oudenaarde, 9636, Belgium

  • Modern Research Associates, PLLC

    RECRUITING

    Dallas, Texas, 75231, United States

  • Mounts Bay Medical Hub

    RECRUITING

    Hayle, TR27 5DT, United Kingdom

  • National Hospital Organization Hizen Psychiatric Medical Center

    RECRUITING

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

  • Newquay Health Centre

    RECRUITING

    Newquay, TR7 1RU, United Kingdom

  • Noguchi Naika Clinic

    RECRUITING

    Tokyo, 165-0031, Japan

  • North Star Medical Research

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Panthera Biopartners - Preston

    RECRUITING

    Preston, PR2 9QB, United Kingdom

  • Penn Medicine: University of Pennsylvania Health System

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Psychiatric Hospital of Henan Province

    RECRUITING

    Xinxiang, 453003, China

  • Pusan National University Yangsan Hospital

    RECRUITING

    Busan, 50612, South Korea

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Rainbow and Sea Hospital

    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

    RECRUITING

    Tokyo, 106-0032, Japan

  • Samoncho Clinic

    RECRUITING

    Shinjuku, 160-0017, 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

    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

  • St Pancras Clinical Research

    RECRUITING

    London, EC2Y 8EA, United Kingdom

  • St Pancras Clinical Research - Eastbourne

    RECRUITING

    Eastbourne, BN23 5UZ, United Kingdom

  • Tatsuta Clinic

    RECRUITING

    Kobe, 651-0097, Japan

  • The Affiliated hospital of Southwest Medical University

    RECRUITING

    Sichuan, 646000, China

  • The Affilicated Kangning Hospital of Ningbo University

    RECRUITING

    Ningbo, 315201, China

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

    RECRUITING

    Seoul, 06591, South Korea

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

    RECRUITING

    Uijeongbu-si, 11765, South Korea

  • 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

  • Tokyo-Eki Center-building Clinic

    RECRUITING

    Chūōku, 103-0027, Japan

  • Tri-Service General Hospital

    RECRUITING

    Taipei, 114, Taiwan

  • Tsukuba University Hospital

    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

  • Velocity Clinical Research, Berlin

    RECRUITING

    Berlin, 10787, Germany

  • Wellness Research Center

    RECRUITING

    Miami, Florida, 33135, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Cheng Du Shi, 610041, China

  • Wickersley Health Centre - Clifton Medical Centre

    RECRUITING

    Rotherham, S65 1DA, United Kingdom

  • 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

    RECRUITING

    Nishi, 733-0011, Japan

  • Zentralinstitut für Seelische Gesundheit

    RECRUITING

    Mannheim, 68159, Germany

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, 310014, China

  • Zhenjiang Mental Health Center

    RECRUITING

    Zhenjiang, 212000, China

  • Zhumadian Psychiatric Hospital

    RECRUITING

    Zhumadian, 463000, China

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