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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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
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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.

What is already known about the treatment

Brenipatide – Brenipatide is an investigational medication currently being studied in clinical trials for the treatment of Alcohol Use Disorder in adults. This drug is being tested to help reduce alcohol consumption in people who struggle with problematic drinking patterns. The medication works at a molecular level by targeting specific brain pathways involved in alcohol cravings and consumption behaviors, though it is still in the research phase and not yet approved for general medical use. Brenipatide is being evaluated in a controlled study comparing different dose levels against placebo to determine its effectiveness and safety in helping patients decrease their alcohol intake and maintain reduced drinking over time.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522312-16-00Protocol codeJ2S-MC-GZMPEstimated enrolment949 patientsSponsorEli Lilly & Co.

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