Clinical trial of MK-6024 in adults with liver scarring from MASH
Research type
Research Study
Full title
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
IRAS ID
1009803
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for ways to treat a type of fatty liver disease called metabolic dysfunction-associated steatohepatitis (MASH).
MASH is liver damage caused by fat building up in liver cells. It happens when the body stores extra fat in the liver, which causes liver inflammation and scarring . Over time, the scarring can stop the liver from working well. MASH often happens in people who are overweight, have diabetes, or have high cholesterol.
Researchers want to learn if a study medicine called efinopegdutide can treat MASH. Efinopegdutide is in a group of medicines that can help weight loss and may also treat MASH.
The goals of this study are to learn:
• If efinopegdutide can lower the amount of fat, inflammation, and scarring in the liver.
• About the safety of efinopegdutide and how well people tolerate it.About 80 people with MASH, 18 to 80 years old will join the study. People will:
• Have liver scarring or liver damage caused by MASH.
• Have controlled type 2 diabetes, or do not have type 2 diabetes.
• Not have another liver disease.People will have an equal chance of receiving one of these treatments:
• Efinopegdutide, the study medicine.
• Placebo, which looks like the study medicine but has no study medicine in it.People will receive their treatment as a weekly injection for about 7 months. Neither the people in the study nor the researchers will know which treatment a person is taking.
People will give blood samples, have liver imaging tests, have physical examinations, and answer questions about how they are feeling. People may be in this study for about 11 months.
People may benefit because the study medicine may treat MASH or stop it from getting worse. There may be risks because the study medicine may not work or may cause health problems.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0374
Date of REC Opinion
12 Jul 2024
REC opinion
Further Information Favourable Opinion