Active not recruitingPHASE2INTERVENTIONAL

Phase 2b Study of GSK4532990 in Adults With NASH

This study is looking for adults with a liver condition called Non-Alcoholic Steatohepatitis, or NASH, who also have significant liver scarring (fibrosis). NASH is a more serious form of non-alcoholic fatty liver disease. We are testing a new medicine, GSK4532990, to see if it can help reduce the scarring and inflammation in the liver. Some participants will receive the new medicine, while others will receive a 'placebo' – a dummy medicine with no active ingredients. This helps us understand if the new medicine is truly effective. The study will last for up to 76 weeks, with treatment for about a year. We want to find out if this new treatment can make a real difference for people living with NASH.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

284

Start

02 Jan 2023

Estimated completion

05 Apr 2027

Nonalcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease

What is this study about?

This study is about an important liver condition called Non-Alcoholic Steatohepatitis, or NASH. Essentially, it means you have inflammation and liver cell damage along with fat in your liver. If NASH isn't managed, it can get worse over time and lead to serious liver scarring, known as fibrosis. When this scarring becomes advanced, it can cause significant health problems.

Researchers are testing a new medicine called GSK4532990. The main goal is to find out if this new medicine can help reduce the amount of scarring in the liver and lower the inflammation in people with NASH and advanced fibrosis. Currently, there aren't many specific medicines for NASH, so finding effective treatments is very important.

By comparing the new medicine to a 'placebo' (a treatment that looks like the real thing but has no active drug), doctors can properly assess if GSK4532990 is effective. This type of research is crucial for developing new and better ways to help people living with NASH improve their liver health.

Key takeaways

This study is testing a new medicine for NASH with significant liver scarring.
It aims to reduce liver scarring and inflammation.
Participants will receive either the new medicine or a dummy medicine (placebo).
The study involves regular clinic visits and two liver biopsies over about 1.5 years.
It's for adults aged 18-75 with specific health conditions related to liver disease.
Your general health will be closely monitored throughout the study.

Who may be eligible?

To join this study, we're looking for adults between 18 and 75 years old. You would generally need to have a Body Mass Index (BMI) of 25 or higher, though for people of Asian origin, a BMI of 23 or higher might be suitable. Your doctor must also believe that your liver problems are due to non-alcoholic fatty liver disease (NAFLD) and you have signs of what's called 'metabolic syndrome' – this can include things like type 2 diabetes, obesity, high cholesterol, or high blood pressure.

An important part of checking if you can join is a liver biopsy. This involves taking a small sample of your liver to look at under a microscope. For this study, the biopsy would need to show specific levels of fat, inflammation, and cell damage, as well as significant liver scarring (rated as F3 or F4). You must also be prepared to have another liver biopsy at the end of the treatment period, around week 52, to see if the medicine has made a difference.

Some things would mean you can't join the study. For example, if you drink more than a certain amount of alcohol each week, or if you've had weight-loss surgery or procedures in the last two years (or plan to during the study). Also, if you've had certain types of cancer in the last two years, you wouldn't be able to participate, unless it was a very common skin cancer or a specific type of cervical cancer that has been successfully treated.

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 between 18 and 75 years old?
Do you have a Body Mass Index (BMI) generally above 25 (or 23 if you are of Asian origin)?
Does your doctor think your liver problems are caused by non-alcoholic fatty liver disease?
Do you have a diagnosis of NASH with significant liver scarring confirmed by a biopsy?
Are you willing and able to have two liver biopsies during the study?
Do you drink less than the equivalent of 14 units of alcohol per week (for females) or 21 units (for males)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement would last up to 76 weeks, which is about a year and a half. For about 52 of those weeks (around a year), you would be taking either the study medicine (GSK4532990) or a placebo (a dummy medicine). Throughout this time, you'll have regular visits to the clinic so the study team can check on your health and how you're responding to the treatment. These visits will include various assessments like blood tests to monitor your liver function and overall health. A key part of the study involves having two liver biopsies: one at the beginning to confirm you meet the criteria, and another around week 52 to see if the treatment has had an effect on your liver scarring and inflammation. The study team will explain all the procedures in detail and ensure you are comfortable.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might benefit if GSK4532990 proves to be an effective treatment for NASH and helps improve your liver condition. You'll also receive regular medical checks and monitoring throughout the study. However, there's no guarantee the treatment will work for you, and like all medicines, GSK4532990 could have side effects, which the study team will discuss thoroughly. There's also some discomfort and a small risk associated with procedures like liver biopsies. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (170)

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

GSK Investigational Site
Verified postcode
Homewood, United States
GSK Investigational Site
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Chandler, United States
GSK Investigational Site
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Chandler, United States
GSK Investigational Site
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Mesa, United States
GSK Investigational Site
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Jonesboro, United States
GSK Investigational Site
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North Little Rock, United States
GSK Investigational Site
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Huntington Park, United States
GSK Investigational Site
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La Jolla, United States
GSK Investigational Site
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Orange, United States
GSK Investigational Site
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Poway, United States
GSK Investigational Site
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Rialto, United States
GSK Investigational Site
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Sacramento, United States

Common questions

What is NASH?

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

What does 'advanced fibrosis' mean?

Fibrosis means scarring in the liver. 'Advanced fibrosis' means there is a significant amount of scarring, which can affect how well your liver works.

What is a 'placebo'?

A placebo is a dummy medicine that looks just like the real drug but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.

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 whether you are receiving the active medicine or the placebo. This is to ensure the results are unbiased.

What is a liver biopsy and why is it needed?

A liver biopsy involves taking a small tissue sample from your liver. It's needed to confirm your diagnosis, check the level of scarring, and see if the study medicine has made a difference.