Active not recruitingPHASE2INTERVENTIONAL

A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

Researchers are investigating a new medicine, efinopegdutide, for a liver condition previously known as NAFLD or NASH, now called MASH (Metabolic Dysfunction-Associated Steatohepatitis). MASH means there's too much fat in the liver, leading to inflammation and scarring. This particular study focuses on people who have MASH with mild liver scarring (compensated cirrhosis). The main goals are to find out if efinopegdutide can reduce the amount of fat, swelling, and scarring in the liver. We also want to understand how safe the medicine is and if people can tolerate it well. Participants will either receive the study medicine or a placebo (a dummy medicine) to compare their effects.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

12 Jul 2024

Estimated completion

06 Aug 2026

Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis NAFLD Metabolic Dysfunction-associated Steatotic Liver Disease Metabolic Dysfunction-associated Steatohepatitis

What is this study about?

This research is looking at a specific liver condition called Metabolic Dysfunction-Associated Steatohepatitis, or MASH for short. You might have heard it called NAFLD or NASH in the past. MASH happens when there's too much fat in your liver, which can lead to swelling and, over time, scarring. If the scarring becomes advanced, it can cause serious liver problems. This study is focusing on people who have MASH where the scarring is still mild (this is called compensated cirrhosis).

The main aim of this study is to test a new medicine called efinopegdutide. We want to see if this medicine can help make the liver healthier by reducing the amount of fat, calming down the swelling, and stopping or even reversing some of the scarring. Understanding how this medicine works could lead to new ways to treat MASH and improve the health of many people.

In addition to checking how effective the medicine is, a very important part of this study is to learn about its safety. We want to make sure that efinopegdutide doesn't cause too many side effects and that people can take it without serious problems. To do this, some people will receive the new medicine, while others will receive a placebo, which looks like the medicine but has no active ingredients. This helps researchers accurately compare if the new medicine is having a real effect.

Key takeaways

This study is testing a new medicine called efinopegdutide for MASH.
It aims to see if the medicine can reduce liver fat, swelling, and scarring.
It's for people with MASH who have mild liver scarring (compensated cirrhosis).
Participation involves regular visits and health checks.
The study also focuses on the safety and how well people tolerate the medicine.
You might receive the new medicine or a placebo (dummy medicine).

Who may be eligible?

To join this study, you need to be between 18 and 80 years old. You must have mild liver scarring (called compensated cirrhosis) that was caused by MASH. You can have type 2 diabetes if it's managed well with diet or tablets, or you might not have diabetes at all.

However, there are reasons why someone might not be able to join. For example, if you have other types of liver disease that aren't MASH (like Hepatitis B or C), or if you have type 1 diabetes, this study isn't suitable for you. Also, if you’ve had weight loss surgery in the last five years, or have a history of pancreas swelling (pancreatitis), you wouldn't be able to take part.

Finally, if you've had major health problems recently, like within the last six months, such as serious heart issues (like a heart attack, angina, or heart failure) or a stroke, this study wouldn't be right for you. The research team needs to make sure it's safe for everyone involved.

Quick self-check

Are you between 18 and 80 years old?
Do you have mild liver scarring (compensated cirrhosis) due to MASH?
Is your type 2 diabetes (if you have it) well managed?
Have you not had weight loss surgery in the last 5 years?
Have you not had a heart attack, stroke, or severe heart problems recently (in the last 6 months)?
Do you NOT have other liver diseases like Hepatitis B or C, or type 1 diabetes?

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 in this study, you would receive either the new study medicine, efinopegdutide, or a placebo (a dummy medicine). You wouldn't know which one you are getting, and neither would the study team, to ensure fair results. Taking the medicine would involve regular visits to the clinic for assessments. These assessments will likely include blood tests, physical examinations, and possibly scans or biopsies to check your liver and overall health.

The research team will closely monitor your health throughout the study. You'll have scheduled appointments to track how you're feeling, whether the medicine is working, and if you're experiencing any side effects. The total length of your participation in the study, including all treatments and follow-up checks, will be explained in detail by the study team. They will also tell you the number and frequency of visits you can expect.

Potential risks and benefits

Taking part in a clinical study might offer some potential benefits, such as accessing a new medicine before it’s widely available, and receiving close medical attention and monitoring. However, there are also potential risks involved, including the possibility of side effects from the study medicine, or that the medicine might not be effective for you. You might also receive a placebo, meaning you wouldn’t get any active treatment from the study medicine itself. It is your right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (68)

The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler, United States
Arizona Clinical Trials ( Site 0158)
Flagstaff, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
Peoria, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
Tucson, United States
California Liver Research Institute ( Site 0113)
Pasadena, United States
Acclaim Clinical Research ( Site 0137)
San Diego, United States
Velocity Clinical Research, Panorama City ( Site 0124)
Van Nuys, United States
Rocky Mountain Gastroenterology ( Site 0127)
Littleton, United States
Synergy Healthcare ( Site 0118)
Bradenton, United States
Homestead Associates in Research, Inc. ( Site 0139)
Homestead, United States
Florida Research Institute ( Site 0116)
Lakewood Rch, United States
Floridian Clinical Research, LLC ( Site 0109)
Miami Lakes, United States

+56 more sites — see the official record for the full list.

Common questions

What is MASH?

MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a liver condition where too much fat builds up, causing swelling and sometimes scarring in the liver.

What is compensated cirrhosis?

Compensated cirrhosis means there is some scarring in the liver, but your liver is still generally working well and coping fine. It's usually a milder form of scarring.

What is efinopegdutide?

Efinopegdutide is the new study medicine being tested. Researchers want to see if it can help reduce liver fat, swelling, and scarring.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It's used to compare against the new medicine to see if it has a real effect.

Can I only join if I have diabetes?

No, you don't have to have diabetes to join. You can have well-controlled type 2 diabetes or no diabetes at all.