RecruitingPHASE3INTERVENTIONAL

A Study of Brenipatide in Participants With Alcohol Use Disorder

This research study is investigating a new potential treatment, brenipatide, for individuals who have alcohol use disorder (AUD) and drink at hazardous levels. The main goal is to find out if brenipatide is both safe to use and effective in helping people reduce or stop drinking, compared to a placebo (a dummy treatment). Participants will be involved in the study for about 56 weeks, which is just over a year. Throughout this time, researchers will closely monitor their health and drinking habits to understand how well the new medication works and if there are any side effects. Your participation would help us learn more about potential new ways to treat AUD.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,100

Start

16 Oct 2025

Estimated completion

01 Apr 2028

Alcohol Use Disorder

What is this study about?

This study is all about finding a new and effective way to help people who are struggling with alcohol use disorder, sometimes called AUD. AUD is a medical condition where a person has problems controlling their drinking, is preoccupied with alcohol, or continues to use alcohol even when it causes problems. The new medication being tested in this study is called brenipatide.

Researchers want to compare brenipatide to a placebo. A placebo looks just like the actual medication but doesn't contain any active drug. This comparison helps scientists understand if any changes seen are truly due to brenipatide or if they might happen anyway. It's a standard and important part of medical research to make sure new treatments are genuinely effective.

By taking part, you would be contributing to vital research that could one day lead to more options for people living with alcohol use disorder. The study will look carefully at whether brenipatide helps people reduce or stop their drinking and if it's safe to use over time.

Key takeaways

The study tests a new drug, brenipatide, for alcohol use disorder.
It compares brenipatide to a placebo (dummy treatment).
Participation lasts about 56 weeks (over a year).
You'll need to self-inject the medication or have help.
Close medical monitoring and regular visits are part of the study.
Your involvement helps advance treatments for alcohol use disorder.

Who may be eligible?

To join this study, you need to be between 18 and 75 years old. If you're in Japan, you need to be at least 20. It's important that you are actively looking for help with your drinking and are motivated to either stop or cut down.

You can't take part if you've recently had problems with other drug use (apart from nicotine or caffeine) within the last six months. Also, if you've had certain thoughts about self-harm or suicide recently, or have a history of serious liver disease related to alcohol, this study might not be suitable for you. You also shouldn't have taken part in another drug study within a certain recent timeframe.

Overall, the study is looking for people who are committed to attending appointments, willing to follow instructions, and can manage self-injecting the study medication (or have someone to help them).

Quick self-check

Are you between 18 and 75 years old (or 20+ if in Japan)?
Are you motivated to stop or cut down your drinking?
Can you commit to around 56 weeks for the study?
Will you be able to give yourself injections or have someone help you?
Do you have certain serious liver conditions or recent drug use issues (excluding nicotine/caffeine)? (If yes to these, you might not be eligible).
Have you recently had specific thoughts about self-harm or suicide? (If yes, you might not be eligible).

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your involvement will last for about 56 weeks, which is just over a year. During this time, you would have regular visits to the study clinic where you'll have health checks and discussions about your progress. You will also need to self-inject the study medication – either brenipatide or the placebo – at home. If you're unable to do this yourself, someone trained can help you.

You'll also be asked to keep track of your information in diaries, either on paper or electronically, and complete questionnaires. These help the researchers understand how you're feeling and how the treatment is working. Throughout the study, your health will be carefully monitored to check for any side effects and to see the effects of the treatment.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help with your alcohol use disorder, and close medical monitoring. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not be effective for you. You will also receive either brenipatide or a placebo, and will not know which one. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (119)

Headlands Research - Scottsdale
Scottsdale, United States· Recruiting
Woodland International Research Group
Little Rock, United States· Recruiting
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, United States· Recruiting
Artemis Institute for Clinical Research
Riverside, United States· Recruiting
Artemis Institute for Clinical Research
San Diego, United States· Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, United States· Recruiting
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, United States· Recruiting
Innovative Clinical Research
Lauderhill, United States· Not yet recruiting
K2 Medical Research - Maitland
Maitland, United States· Recruiting
K2 Medical Research ORLANDO
Maitland, United States· Recruiting
Life Arc Research Centers - Miami
Miami, United States· Recruiting
Wellness Research Center
Miami, United States· Recruiting

+107 more sites — see the official record for the full list.

Common questions

What is brenipatide?

Brenipatide is a new medication being tested to see if it can help people with alcohol use disorder reduce or stop their drinking.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medication but doesn't contain any active drug. It helps researchers compare the new treatment's effects.

How long will I be in the study?

If you join, you will be part of the study for about 56 weeks, which is roughly one year and two months.

Will I know if I'm getting the real medication or the placebo?

No, you won't know if you're receiving brenipatide or the placebo. This is to ensure fair results for the study.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point and for any reason, without it affecting your regular medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.