Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b Randomized, Double-Blind Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults with Precirrhotic Nonalcoholic Steatohepatitis

This research study is investigating a new medication called efinopegdutide (also known as MK-6024) for adults who have a liver disease called non-alcoholic steatohepatitis, or NASH. People with NASH have fat in their liver, along with inflammation and damage, which can lead to scarring (fibrosis). The study aims to see if efinopegdutide can help improve NASH without making the scarring worse. It will compare efinopegdutide to a different medicine, semaglutide, or a placebo (a dummy treatment with no active drug). Researchers will check how well the medicine works and if it has any side effects over about a year. All adults 18 and over, both men and women, can potentially take part.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

21 Aug 2023

What is this study about?

This research is looking into a condition called non-alcoholic steatohepatitis, which is often shortened to NASH. NASH is a serious type of fatty liver disease that isn't caused by drinking alcohol. In people with NASH, too much fat builds up in the liver, leading to inflammation and liver cell damage. Over time, this can cause scarring, known as fibrosis. If the scarring becomes severe, it can lead to more serious liver problems like cirrhosis and liver failure.

Currently, there aren't many specific medicines for NASH, so finding new treatments is really important. This study is testing a new medicine called efinopegdutide (also known as MK-6024). Researchers want to find out if this medicine can help improve or even clear up NASH in adults before the scarring becomes too advanced.

The study will compare efinopegdutide with another medicine called semaglutide, which is sometimes used for similar conditions, and also with a 'placebo'. A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. This helps researchers understand if any changes are truly due to the new medicine or just other factors. The main things the study will look for are whether the NASH improves without the liver scarring getting worse, and also whether the medicine is safe and doesn't cause too many side effects.

Key takeaways

This study is testing a new medicine (efinopegdutide) for non-alcoholic steatohepatitis (NASH).
It compares efinopegdutide with an existing medicine (semaglutide) and a dummy treatment (placebo).
The main goal is to see if the new medicine improves NASH without making liver scarring worse.
Participation involves regular clinic visits and various health checks over about a year.
The study is for adults over 18 with NASH, before significant liver scarring (cirrhosis) has developed.

Who may be eligible?

This study is open to adults who are at least 18 years old. Both men and women can take part.

You would be considered for this study if you have been diagnosed with non-alcoholic steatohepatitis, which is a type of fatty liver disease. The study is specifically looking for people whose liver scarring (fibrosis) hasn't yet become very severe, sometimes called 'precirrhotic' NASH.

The research team will need to check your medical history and do some tests to make sure that the study is a safe and suitable option for you.

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 of age or older?
Have you been diagnosed with non-alcoholic steatohepatitis (NASH)?
Has a doctor told you that your NASH is not yet in the advanced scarring stage (cirrhosis)?
Are you able and willing to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve regular visits to a clinic over about a year. You would be given either the new medicine (efinopegdutide), another existing medicine (semaglutide), or a placebo. You wouldn't know which one you are receiving, nor would your study doctor, to keep the results fair and unbiased.

Throughout the study, you would have various assessments. These would likely include blood tests, physical examinations, and potentially liver scans or biopsies (where a small sample of your liver is taken for examination). These tests help the doctors understand how your liver is responding to the treatment and to monitor for any side effects. You would also have regular check-ups to discuss your health and any concerns you might have.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medicine for NASH that could improve your liver condition, even if it's not yet approved for general use. You would also receive close medical attention and monitoring. However, there are potential risks, as any medicine can have side effects. These side effects could range from mild to more serious, and the researchers will carefully monitor you for them. There is also no guarantee that the treatment will work for you. Remember, deciding to join is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Spain
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Unverified
Belgium
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Unverified
Austria
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Unverified
Czechia
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Unverified
Portugal
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Unverified
Italy
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Unverified
France
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Unverified
Hungary

Common questions

What exactly is NASH?

NASH stands for Non-Alcoholic Steatohepatitis. It's a liver condition where fat builds up in the liver, along with inflammation and damage, which can lead to scarring. It's not caused by drinking alcohol.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the study medicine but doesn't contain any active drug. It helps researchers fairly compare how well the real medicine works.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving efinopegdutide, semaglutide, or the placebo. This helps ensure fair and accurate results.

How long does the study last?

The main treatment period for this study is about 52 weeks, which is roughly one year. You would have regular visits and assessments during this time.

What happens if I change my mind during the study?

You are free to stop participating in the study at any time, for any reason, without it affecting your future medical care. Your decision is entirely your own.