A study of brenipatide compared to placebo for the treatment of adults with alcohol use disorder

3 1

What is this study about?

This study is looking at Alcohol Use Disorder, which is a condition where a person has difficulty controlling their drinking despite it causing problems in their life. The treatment being tested is called Brenipatide, also known by its code name LY3537031, which is given as an injection under the skin using a pre-filled syringe. Some people in the study will receive Brenipatide while others will receive placebo. The purpose of this study is to see if Brenipatide works better than placebo in helping adults with Alcohol Use Disorder reduce their drinking.

The study is divided into two periods. In the first period, people will receive either Brenipatide at different dose levels or placebo to find out if the medicine can help reduce behaviors related to Alcohol Use Disorder. The study will measure changes in drinking patterns using a method called the Timeline Followback Method, which tracks drinking behavior over time. In the second period, people who responded well to Brenipatide in the first period will continue taking the medicine to see if it can help them maintain the reduction in alcohol use over a longer time.

During the study, people will need to give themselves injections of the study medicine, keep track of their drinking and other information in diaries, attend all required visits, and answer questions about their health and drinking habits. The study will look at how safe the medicine is and whether it helps people who want to stop drinking or cut down on the amount they drink.

1 Treatment Period 1

During this period, you will receive either brenipatide or placebo. Brenipatide is the investigational medicine being tested in this study. A placebo looks like the medicine but contains no active ingredient.

The medicine will be given as an injection under the skin using a pre-filled syringe. You will give yourself these injections as instructed.

The study will test different dose levels of brenipatide to determine which works best.

Throughout this period, you will need to record your alcohol consumption in a study diary using the Timeline Followback Method. This means tracking your drinking patterns and behaviors on a regular basis.

You will be required to attend all scheduled visits during this period.

2 Treatment Period 2

If you responded well to brenipatide during Period 1, you may continue into this second treatment period.

This period is designed to evaluate whether brenipatide can help maintain a reduction in alcohol consumption over a longer time.

You will continue to receive brenipatide injections under the skin using pre-filled syringes.

You will need to continue recording your alcohol consumption in the study diary.

You must attend all required visits and follow the instructions for storing and using the medicine.

The study is expected to continue until approximately April 2028.

Who Can Join the Study?

  • You must be motivated to stop or reduce your alcohol drinking
  • You must be willing to participate in the entire study and attend all required visits
  • You must be willing to follow all study requirements, which include giving yourself the study medicine, storing and using the medicine as instructed, completing study diaries, and answering questionnaires
  • You must be an adult, which means you are 18 years of age or older
  • Both men and women can participate in this study

Who Cannot Join the Study?

  • The source data does not contain specific exclusion criteria for this clinical trial
  • This means the detailed list of reasons why someone cannot participate in this study has not been provided in the available information
  • Generally, clinical trials have exclusion criteria to protect participant safety, but these specific details are not available in the current data

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kormont Kluisbergen Belgium

Other Sites

Site Name City Country Status
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Central Institute of Mental Health Mannheim Germany
Anima Alken Belgium
Klinische Forschung Hamburg GmbH Hamburg Germany
Klinische Forschung Schwerin GmbH Schwerin Germany
Mcpvttcm Mechelen Belgium
Fhxsybhqxj Gukw Offenbach Am Main Germany
Ksmttzvzf Fmgqiqdhe Dauuuov Grya Dresden Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.01.2026
Germany Germany
Recruiting
15.01.2026

Trial locations

Investigated Drugs:

Brenipatide is an investigational medication being studied for the treatment of alcohol use disorder in adults. In this trial, it is being tested to see if it can help reduce alcohol consumption in participants compared to a placebo (an inactive substance with no medicine in it).

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare the effects of brenipatide and help researchers determine if brenipatide is truly effective in treating alcohol use disorder.

Alcohol Use Disorder – Alcohol Use Disorder is a medical condition characterized by an impaired ability to stop or control alcohol consumption despite negative social, occupational, or health consequences. The disorder develops when drinking alcohol becomes so frequent or excessive that it changes the brain’s chemistry and creates a physical dependence on the substance. People with this condition often experience strong cravings for alcohol and may continue drinking even when it causes problems in their relationships, work, or daily activities. The disorder can progress from mild to severe, with increasing difficulty in controlling drinking behaviors and growing amounts of time spent obtaining, using, or recovering from alcohol. As the condition advances, individuals may need to drink more alcohol to achieve the same effects due to increased tolerance. The disorder is marked by persistent patterns of excessive alcohol consumption that interfere with a person’s ability to function normally in everyday life.

Trial ID:
2025-522312-16-00
Protocol code:
J2S-MC-GZMP
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Efficacy of high- and low-dose psilocybin in preventing relapse in adults with severe alcohol use disorder and depressive symptoms after detoxification

    Recruiting

    3 1 1
    Investigated Diseases:
    Investigated Drugs:
    France
  • Study on the Effects of Cannabidiol and Naltrexone on Alcohol Craving in Patients with Alcohol Dependence

    Recruiting

    2 1
    Investigated Diseases:
    Investigated Drugs:
    Germany