Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption (Part A) and Alcohol Craving (Part B) in Subjects Diagnosed with Moderate to Severe Alcohol Use Disorder and Seeking Treatment

This research study is testing a new medicine, called Sunobinop, for people who have a medical condition called alcohol use disorder (AUD). AUD means someone has trouble controlling their drinking. The study aims to find out if Sunobinop can help people drink less often and reduce the amount of alcohol they drink on days they do drink heavily. Researchers will compare Sunobinop to a 'dummy' pill (placebo) to see if it really makes a difference. The study is divided into two parts; one part focuses on reducing overall alcohol use, and the other looks at reducing cravings for alcohol. Your doctor might suggest this study if you are looking for new treatment options.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Imbrium Therapeutics LP

Enrolment target

100

Start

07 May 2025

Alcohol use disorder (AUD).

What is this study about?

This study is a research project looking into a new treatment for alcohol use disorder (AUD). AUD is when someone has problems controlling their drinking, which can affect their health, work, and relationships. It's a common condition, and researchers are always looking for better ways to help people.

The new medicine being tested is called Sunobinop. The study wants to find out if taking Sunobinop can help people drink less alcohol, particularly on days when they might normally drink a lot. It also aims to see if the medicine can help reduce the strong urges, or cravings, to drink alcohol. This is a 'Phase 2' study, which means it's an early stage of testing where researchers are trying to understand if the medicine works and find the right dose.

To make sure the results are reliable, some people will receive Sunobinop, and others will receive a 'placebo.' A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers know if any changes are due to the medicine itself or other factors. Both you and your study doctor won't know whether you're taking Sunobinop or the placebo, which helps keep the study fair and unbiased.

Key takeaways

This study is testing a new medicine called Sunobinop for alcohol use disorder.
It aims to see if Sunobinop can help reduce heavy drinking and alcohol cravings.
Participants will receive either Sunobinop or a placebo (dummy pill).
Regular clinic visits and assessments of drinking habits will be part of the study.
The study is for adults aged 18 and over who are seeking treatment for AUD.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. The study is open to both men and women.

You must have a diagnosis of moderate to severe alcohol use disorder and be actively looking for treatment or support for your drinking. This means you've been finding it hard to control your alcohol use and want to make a change.

There will be other health checks and criteria that the study team will discuss with you to make sure the study is safe and right for you. For example, certain medical conditions or medications might mean you can't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of moderate to severe alcohol use disorder?
Are you actively seeking treatment to reduce or stop your alcohol use?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either Sunobinop or a placebo tablet to take regularly. You won't know which one you're taking, and neither will your study doctor. Throughout the study, you'll have regular appointments at the clinic. During these visits, the study team will ask you questions about your drinking habits, your general health, and how you're feeling. They will use a special interview method called the 'Timeline Followback' to understand how much and how often you've been drinking. These checks help the researchers see if the medicine is making a difference. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You could receive a new medicine that might help you manage your alcohol use, and you'll have regular medical support and monitoring. However, there are also potential risks, as with any medicine. We don't yet know all the side effects of Sunobinop, and you might experience some, or you might receive the placebo and not the active drug. Your health will be closely monitored to ensure your safety. It's important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania

Common questions

What is alcohol use disorder (AUD)?

AUD is a medical condition where a person has difficulty controlling their alcohol intake, leading to problems in their life. It can range from moderate to severe.

What is Sunobinop?

Sunobinop is the name of the new medicine being tested in this study to see if it can help people with alcohol use disorder.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but doesn't contain any active drug. It's used to compare against the active medicine.

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

No, both you and your study doctor won't know if you're taking Sunobinop or the placebo. This helps ensure the study results are fair and accurate.

How long will the study last?

The full duration of your participation, including visits and follow-up, will be explained by the study team, as this information is not provided here.