Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

17 β-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Nonalcoholic Steatohepatitis

This research is a Phase 2 study investigating a new drug called GSK4532990 for adults with Non-Alcoholic Steatohepatitis, or NASH. NASH is a serious type of fatty liver disease that can lead to liver damage and scarring. The study is designed to find out how safe and effective the new drug is compared to a dummy treatment (placebo). Researchers want to see if the drug can help reduce liver scarring and improve the overall condition of the liver after 52 weeks. They are looking for improvements in liver health without the condition getting worse. The study involves a range of participants aged 18 and older, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

08 Mar 2024

What is this study about?

This study, called HORIZON, is looking into a new drug treatment for a liver condition known as Non-Alcoholic Steatohepatitis, or NASH. NASH is a type of fatty liver disease where there’s fat in the liver, along with inflammation and liver cell damage. This can lead to scarring of the liver over time, which doctors call fibrosis. If not managed, this scarring can become very serious. Currently, there aren't many specific treatments for NASH, so finding new options is very important.

The main goals of this study are to decide if the new drug, GSK4532990, can make a real difference for people with NASH. Researchers want to see if the drug can help reduce the scarring in the liver (fibrosis) and also calm down the inflammation and damage that define NASH. They're specifically looking for improvements after about a year of treatment, checking if scarring gets better without the overall disease getting worse, or if the NASH can clear up without the scarring getting worse.

This is a 'Phase 2b' study, which means it’s still in the earlier stages where doctors are trying to understand if the drug works, how well it works, and what side effects it might have. Participants will either receive the new drug or a ‘placebo’, which is a dummy treatment like a salt water injection, to fairly compare the effects. Understanding these results will help decide if this new drug should be studied further in larger trials.

Key takeaways

This study tests a new drug (GSK4532990) for NASH.
It aims to reduce liver scarring and improve NASH.
Participants will receive either the drug or a dummy treatment (placebo).
The treatment period is about one year.
It's for adults (18+) with NASH, both men and women.
Taking part involves regular visits and health checks.

Who may be eligible?

To join this study, you need to be an adult, meaning you must be at least 18 years old. There is no upper age limit, so older adults can also take part. The study is open to both men and women.

Critically, you must have been diagnosed with Non-Alcoholic Steatohepatitis (NASH). This is a specific type of liver condition where you have fat in your liver, along with inflammation and damage to your liver cells. The study is designed for people who specifically have this condition.

While the exact details are not listed here, typically, other factors like your overall health, other medical conditions you might have, and medications you are currently taking would also be considered. These additional criteria are important for making sure the study is safe for you and that the results will be clear.

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?
Have you been diagnosed with Non-Alcoholic Steatohepatitis (NASH)?
Are you able to attend regular clinic visits?
Are you comfortable with receiving injections and having blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you're a good fit. This might involve blood tests, physical exams, and other checks related to your liver condition. If you qualify, you would be randomly assigned to either receive the new study drug, GSK4532990, or a placebo, which looks identical but has no active medication. The study is 'double-blind', meaning neither you nor your study doctor will know which treatment you are receiving. The intervention mentioned "0.9% Sodium Chloride Injection" suggests that the medication is given through an injection, possibly intravenously (into a vein) or subcutaneously (under the skin).

Over the 52-week (about one year) treatment period, you would have regular visits to the study clinic. These visits would likely involve more blood tests, physical examinations, and possibly liver biopsies to check for changes in your liver scarring and inflammation. You would also be asked about any side effects or changes in your health. After the main treatment period, there might be follow-up visits to continue monitoring your health, even after you stop taking the study medication. The total duration of your involvement, including screening and follow-up, could extend beyond the 52-week treatment phase.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment that could improve your NASH or liver scarring, which is not yet available to everyone. You'd also receive close medical attention and monitoring. However, there are potential risks, like experiencing side effects from the study medication, or the treatment might not work for you. There are typical risks associated with medical procedures like blood tests or biopsies. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Greece
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Unverified
Italy
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Unverified
Belgium
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Unverified
Spain
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Unverified
France

Common questions

What is NASH?

NASH stands for Non-Alcoholic Steatohepatitis. It's a liver condition where you have fat in your liver, along with inflammation and liver cell damage, which can lead to scarring.

What is a 'placebo'?

A placebo is a dummy treatment, like a salt water injection, that doesn't contain any active medication. It helps researchers compare the real drug's effects accurately.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you're receiving the active drug or the placebo.

How long will the treatment last?

The main treatment period in this study is planned for 52 weeks, which is about one year.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.