A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults with Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
Metabolic dysfunction-associated steatohepatitis (MASH) is a condition where excess fat builds up in the liver, causing inflammation and scarring. Over time, this scarring can lead to cirrhosis, where the liver becomes stiff and damaged. This clinical trial is testing an experimental medicine called efinopegdutide (MK-6024). Researchers want to find out whether efinopegdutide can safely reduce fat in the liver and help improve liver stiffness or body weight. Adults with early-stage cirrhosis caused by MASH can take part. Participants will be placed by chance into groups receiving either different doses of the study medicine or a placebo (a dummy drug with no active ingredients). The study lasts at least 28 weeks, during which doctors will closely track any side effects and perform scans to see how well the liver is working.
At a glance
What is this study about?
The liver is a vital organ that processes nutrients, filters blood, and helps fight infections. Sometimes, too much fat builds up in the liver cells. When this fat causes swelling, irritation, and damage, doctors call it MASH (metabolic dysfunction-associated steatohepatitis). If the inflammation continues over many years, hard scar tissue can replace healthy tissue. When scarring becomes advanced, it is called cirrhosis. Even if the liver can still do its everyday jobs, advanced scarring puts a person at risk of serious health problems.
Currently, there are very few approved treatments that directly reverse liver damage caused by MASH. This research study is looking at an experimental medicine called efinopegdutide (also known as MK-6024). Scientists believe this medicine may help the body burn off liver fat, calm inflammation, and potentially slow down or reverse scar tissue formation.
By comparing efinopegdutide to a placebo (a harmless dummy treatment), researchers hope to learn whether the drug is truly effective and safe. Finding a medicine that reduces liver fat and scarring could make a big difference for people living with chronic liver conditions in the future.
Key takeaways
- The trial tests whether a new drug called efinopegdutide can reduce liver fat and scarring in adults with MASH.
- It is designed for people with compensated cirrhosis, meaning the liver is scarred but still functioning.
- Participants will be randomly assigned to receive either the study drug or a dummy medicine (placebo).
- Treatment and monitoring last for around 28 weeks, using regular check-ups, blood tests, and scans.
- Joining is completely voluntary, and you can leave the study at any time without losing your regular care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with compensated cirrhosis caused by MASH. 'Compensated' means that although there is severe scarring in the liver, the organ is still able to perform its necessary daily functions, and the person does not have severe complications like fluid buildup in the tummy or internal bleeding.
Both men and women may be eligible. However, you will need to undergo medical tests and scans to confirm the level of fat and scarring in your liver before you can join.
People with other types of liver disease (such as active viral hepatitis or liver damage mainly caused by alcohol) or those who have advanced liver failure will not be able to take part. The study team will review your full medical history and current medications to make sure taking part is safe 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.
- I am aged 18 or older.
- I have been diagnosed with fatty liver disease or MASH.
- My doctor has told me I have liver scarring or early-stage cirrhosis.
- My liver is still working and I do not have severe liver failure symptoms.
- I am willing to attend regular hospital check-ups and undergo liver scans over 28 weeks.
What does participation involve?
Taking part in this study lasts for at least 28 weeks. During this time, you will receive either the study medicine (efinopegdutide) at one of several doses or a placebo. Neither you nor your study doctor will choose or know which one you receive, which keeps the results fair and unbiased.
You will need to make regular visits to a hospital or clinical trial clinic. At these appointments, the medical team will monitor your general health, check your weight, take blood samples, and ask about any symptoms or side effects. You will also have special non-invasive liver scans, such as MRI scans and ultrasound-based stiffness tests (called elastography), to measure fat levels and scar tissue in your liver without needing surgery.
All study-related appointments, tests, and medications will be provided at no cost, and your health will be watched very closely throughout the trial.
Potential risks and benefits
Locations (2)
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Common questions
What is a placebo?
A placebo looks just like the real medicine but contains no active ingredients. It helps researchers see whether changes in health are truly caused by the study drug.
Will I have to pay for the study treatment?
No. The trial medicine, scans, and doctor visits related to the study are provided free of charge.
Can I carry on taking my regular prescriptions?
In many cases, yes, but the study team will review all your current medicines to make sure they do not interfere with the trial drug.
What happens if I feel unwell during the trial?
You will be given contact details for the study team to reach them at any time. If you have unpleasant side effects, the doctors can treat them or stop the study medicine if needed.
Do I have to stay in the study until the end?
No. Taking part is completely voluntary. You can choose to stop participating at any point, and your standard care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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