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A Study of Brenipatide Compared to Placebo in Adults with Moderate-to-Severe 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 in adults who have moderate-to-severe forms of this condition. Alcohol Use Disorder is a medical condition where a person has difficulty controlling their alcohol drinking despite it causing problems in their life. The study will test a medicine called Brenipatide, which is also known by its code name LY3537031. The medicine comes as a solution that 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 the study is to see if Brenipatide works better than placebo in helping people with Alcohol Use Disorder reduce their drinking.

The study is divided into two periods. In the first period, researchers want to find out if Brenipatide is better than placebo at helping people change their drinking behaviors. Different dose levels of Brenipatide will be tested to see which works best. During this time, the amount and pattern of alcohol use will be tracked using a method called the Timeline Followback Method, which involves keeping track of drinking on a calendar. In the second period, people who responded well to Brenipatide in the first period will continue taking the medicine to see if it helps them maintain the reduction in their alcohol use over a longer time.

People taking part in this study need to be motivated to stop drinking or reduce how much they drink. They will need to attend all required study visits and follow the study instructions, which includes giving themselves the medicine injections, storing and using the medicine properly, filling out study diaries about their drinking, and answering questions from the study team. The study will track how participants are doing throughout the treatment periods to understand whether Brenipatide can help people with Alcohol Use Disorder manage their drinking.

The research process

The trial runs in 4 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. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

    The medication will be administered as a solution for injection using a pre-filled syringe.

    The route of administration is subcutaneous, which means the injection will be given under the skin.

    You will be required to self-administer the injections as instructed.

    The purpose of this period is to determine if brenipatide is more effective than placebo in reducing alcohol consumption.

  2. Step 2

    Recording and Monitoring Activities

    Throughout the study, you will need to complete study diaries to record your activities and behaviors.

    You will be asked to track your alcohol consumption using a method called Timeline Followback, which involves recalling and recording your drinking patterns.

    You will need to answer questionnaires provided during the study visits.

    You must store and use the medication according to the instructions provided.

  3. Step 3

    Treatment Period 2

    If you respond positively to brenipatide during Period 1, you may continue into Period 2.

    This period is designed to evaluate whether brenipatide can help maintain the reduction in alcohol consumption that was achieved in Period 1.

    You will continue to receive brenipatide injections during this period.

    The medication will continue to be administered subcutaneously using pre-filled syringes.

    You will continue to self-administer the injections as instructed.

  4. Step 4

    Ongoing Study Visits

    You will be required to attend all scheduled study visits throughout both treatment periods.

    During these visits, your progress and any side effects will be monitored.

    You will continue to complete diaries and questionnaires as requested.

    The study is expected to continue until approximately April 2028.

Who can join the trial?

5 criteria

  • You must be motivated to stop drinking alcohol or to reduce the amount of alcohol you drink
  • You must be willing to participate in the entire study and attend all required visits
  • You must be willing to follow all study requirements, including giving yourself the study medicine, storing and using the medicine as instructed, filling out study diaries, and completing questionnaires, which are forms with questions about your health and experiences
  • You must be an adult
  • Both men and women can participate in this study

Who cannot join the trial?

4 criteria

  • The study information provided does not contain specific exclusion criteria, which are the reasons why someone cannot participate in this clinical trial.
  • Exclusion criteria are important rules that help protect patients and ensure the study results are accurate.
  • These criteria typically include things like certain medical conditions, medications you are taking, or other health factors that might make the study unsafe for you or affect the results.
  • Without access to the complete exclusion criteria list, we cannot provide the specific reasons why you might not be able to join this particular study.
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Investigated drugs

  • Brenipatide

    is an investigational medication being studied for the treatment of moderate-to-severe alcohol use disorder in adults. This medication is being tested to see if it can help reduce alcohol consumption in people who struggle with drinking problems.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against brenipatide to determine if brenipatide actually works better than no treatment at all.

What is already known about the treatment

Brenipatide – Brenipatide is an investigational medication currently being studied in clinical trials for the treatment of moderate-to-severe alcohol use disorder in adults. This drug is being tested in a Phase 3 trial to determine if it can help reduce alcohol consumption more effectively than placebo. The medication works by targeting specific molecular pathways in the brain that are involved in alcohol dependence and craving behaviors. Brenipatide is being evaluated at different dose levels to find the most effective and safe treatment option for people struggling with problematic alcohol use.

Investigated diseases

Alcohol Use Disorder – Alcohol Use Disorder is a medical condition where a person has difficulty controlling their alcohol consumption despite negative consequences. The disorder involves a pattern of alcohol use that leads to significant problems in daily life, relationships, work, or health. People with this condition often experience a strong urge or craving to drink alcohol and may find it hard to limit how much they consume. Over time, individuals may develop tolerance, meaning they need to drink more alcohol to achieve the same effects. When they try to cut down or stop drinking, they may experience uncomfortable physical and emotional symptoms. The condition can range from mild to severe depending on how many symptoms a person experiences and how much alcohol use interferes with their life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522313-38-00Protocol codeJ2S-MC-GZMEEstimated enrolment1 090 patientsSponsorEli Lilly & Co.

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