RecruitingPHASE3INTERVENTIONAL

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

This research study is investigating a new medication called brenipatide for individuals dealing with moderate to severe alcohol use disorder. The main goal is to find out if brenipatide is both safe and helpful when compared to a placebo, which is an inactive substance that looks just like the real medication. Participants will be involved for about 56 weeks. This study aims to help those who are motivated to reduce or stop their alcohol consumption. By participating, you would be helping researchers understand if this new treatment could be a valuable option for many people in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,100

Start

15 Oct 2025

Estimated completion

01 Apr 2028

Alcohol Use Disorder

What is this study about?

This study is about a new medicine called brenipatide, and how it might help people who struggle with moderate to severe alcohol use disorder. Alcohol use disorder is a condition where a person has trouble controlling their drinking, even when it causes problems in their life. The researchers want to see if brenipatide can help people cut down or stop drinking, and if it's safe to use.

To find this out, they will compare brenipatide with a 'placebo.' A placebo is a dummy pill or injection that doesn't contain any active medicine. This helps the researchers understand if the changes people experience are truly due to the medicine or something else. Half of the people in the study will get brenipatide, and the other half will get the placebo. Neither you nor your study doctor will know which one you are receiving.

This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups of people and shown some promise. This larger study is needed to confirm its safety and effectiveness before it can potentially be made available to more people. Taking part could help improve treatments for alcohol use disorder.

Key takeaways

This study is testing a new medicine called brenipatide for alcohol use disorder.
It aims to see if brenipatide is safe and helps people reduce or stop drinking.
Participants will receive either brenipatide or a dummy medicine (placebo).
The study involves regular clinic visits and self-injections of the study medicine.
Participation lasts about 56 weeks and helps advance understanding of treatments.
You can withdraw from the study at any time without penalty.

Who may be eligible?

You might be able to join this study if you are between 18 and 75 years old and are actively looking for help to stop or reduce your drinking. It's important that you are able to attend all the study visits and follow the instructions carefully throughout the study, which includes things like keeping diaries and giving yourself injections.

However, some things would mean you can't take part. For example, if you've had problems with certain other types of substance use (other than alcohol, nicotine, or caffeine) in the last six months, or if you've had recent thoughts or actions related to harming yourself. Also, if you have severe liver disease, you wouldn't be able to join this study. The study team will check for these and other conditions to make sure the study is safe for you.

Quick self-check

Are you between 18 and 75 years old?
Are you motivated to cut down or stop your drinking?
Are you able to attend all study visits and follow instructions carefully?
Have you had no serious substance use issues (other than alcohol, nicotine, or caffeine) in the last 6 months?
Have you not had recent thoughts or actions to harm yourself in the last 6 months?
Do you have no severe liver disease?

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 would last for about 56 weeks, which is just over a year. During this time, you would have regular visits to the study clinic. You would need to give yourself the study medicine (either brenipatide or the placebo) as an injection at home. You'll be shown exactly how to do this safely and how to store the medicine properly.

You'll also be asked to keep track of your progress by filling out electronic or paper diaries and completing questionnaires. These help the study team understand how you are doing. The team will provide you with all the necessary materials and support throughout your participation.

Potential risks and benefits

By taking part, you might benefit from receiving a new potential treatment for alcohol use disorder, though there's also a chance you could receive the placebo. Your participation provides valuable information that could help others in the future, even if it doesn't directly benefit you. As with any medication, brenipatide may have side effects, and these will be explained to you in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (123)

Parkway Medical Center
Birmingham, United States· Recruiting
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
San Diego, United States· Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, United States· Recruiting
Mountain Mind - Denver
Denver, United States· Recruiting
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, United States· 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

+111 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 moderate to severe alcohol use disorder.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active drug. It helps researchers understand if the new medicine is actually working.

How long will the study last?

If you join, your participation in the study will last for approximately 56 weeks, which is a little over a year.

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

Neither you nor your study doctor will know whether you are receiving brenipatide or the placebo during the study.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and doing so will not affect your future 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.