RecruitingPHASE2INTERVENTIONAL

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease

This research study is looking into a new medicine called GSK4532990 for adults between 18 and 70 years old who have liver disease caused by drinking alcohol. The main goals are to find out if the medicine is safe to use and if it can help improve the liver condition. To do this, some participants will receive the new medicine, while others will be given a placebo – which looks like the medicine but contains no active drug. This is common practice in studies to fairly compare the new treatment. The study aims to gather important information that could potentially lead to a new treatment option for alcohol-related liver disease.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

393

Start

27 Sep 2024

Estimated completion

07 Mar 2028

Liver Diseases, Alcoholic

What is this study about?

This study is about a new medicine, called GSK4532990, for people whose liver has been damaged because of alcohol consumption. Your liver is a very important organ that helps clean your blood, digest food, and store energy. When it's affected by alcohol over time, it can lead to serious health problems. The researchers want to find out if this new medicine can safely help improve the health of the liver in people with alcohol-related liver disease.

To do this, some people taking part in the study will receive the new medicine, while others will get a placebo. A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. This is a standard way to test new medicines, as it helps compare the effects of the new drug against not having it at all.

The study also aims to check for any side effects of the new medicine. Research like this is really important because it helps doctors develop better ways to treat diseases. If this medicine proves to be safe and effective, it could offer a new treatment option for people with alcohol-related liver disease in the future.

Key takeaways

It's a study for adults aged 18-70 with alcohol-related liver disease.
It tests a new medicine (GSK4532990) against a dummy pill (placebo).
The main goals are to check for safety and if the medicine helps the liver.
Participation involves regular clinic visits, tests, and taking study medicine.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have liver disease linked to alcohol. You must be willing to follow all the study instructions and attend appointments. Women must meet some extra health requirements to join.

There are also reasons why you might not be able to take part. For example, if you have other serious health problems affecting your organs, certain types of cancer (apart from very specific skin or womb cancers), or if you've already had an organ transplant (except for eye transplants). People who are being considered for an organ transplant or have conditions like poorly controlled high blood pressure, certain heart problems, or blood clots in their liver veins would also not be able to join.

Also, if recent blood tests show that your liver or kidney function is outside specific limits, or if you have other main causes of liver disease not related to alcohol, you wouldn't be able to participate. This is to make sure the study focuses on people who are most likely to benefit and for whom the medicine can be safely tested.

Quick self-check

Are you between 18 and 70 years old?
Do you have liver disease caused by alcohol?
Are you able to attend appointments and follow study instructions?
Do you have any serious organ problems or certain types of cancer?
Have you had an organ transplant (other than eye transplants)?
Is your high blood pressure well-controlled, and do you have no recent major heart or circulation problems?

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

What does participation involve?

If you decide to take part, you'll be given either the new medicine (GSK4532990) or a placebo (a dummy pill). You won't know which one you're getting, and neither will your study doctor, until the study is over. You will need to take the study medicine regularly as instructed. You'll have several visits to the clinic for various checks. These visits will involve blood tests, physical examinations, and possibly other tests to see how the medicine is affecting your body and liver function. You'll also be asked about your health and any side effects you might be experiencing. The study will last for a certain period, and there will be follow-up appointments even after you stop taking the medicine to ensure your health is stable. The total duration of the study will involve regular clinic visits over several months.

Potential risks and benefits

Taking part in a clinical study might offer the potential benefit of trying a new medicine that could help your liver condition, especially if other treatments haven't worked well for you. However, there's no guarantee the medicine will help, and you might receive a placebo. Like all medicines, this new drug could have side effects, which may range from mild to more serious. The study team will carefully monitor you for any problems. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (131)

GSK Investigational Site
Chandler, United States· Recruiting
GSK Investigational Site
Phoenix, United States· Recruiting
GSK Investigational Site
Tucson, United States· Recruiting
GSK Investigational Site
Davis, United States· Recruiting
GSK Investigational Site
Los Angeles, United States· Recruiting
GSK Investigational Site
Los Angeles, United States· Recruiting
GSK Investigational Site
Brandon, United States· Recruiting
GSK Investigational Site
Miami Lakes, United States· Recruiting
GSK Investigational Site
Atlanta, United States· Recruiting
GSK Investigational Site
Indianapolis, United States· Recruiting
GSK Investigational Site
Topeka, United States· Recruiting
GSK Investigational Site
Marrero, United States· Recruiting

+119 more sites — see the official record for the full list.

Common questions

What is alcohol-related liver disease?

It's damage to the liver caused by drinking too much alcohol over time, which can make it harder for your liver to work properly.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but has no active drug inside. It helps researchers compare the new medicine fairly.

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

No, during the study, neither you nor your study doctor will know. This is to ensure the study results are as fair and accurate as possible.

Can I continue my other medicines?

The study team will review all your current medicines to make sure they are compatible with the study. You may need to have stable use of some medicines before joining.

How long will I be in the study?

The study involves regular visits over a period of time, including follow-up after stopping the medicine. The exact duration will be explained by the study team.

How to find out more

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com 877-379-3718 Official trial record

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