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

What Was Tested

The trial (phase 2) is built around Efinopegdutide for fatty liver & elevated liver enzymes.

Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH).

MASH was formerly called non-alcoholic steatohepatitis (NASH).

Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn: * If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver * About the safety of efinopegdutide and how well people tolerate it.

It had two arms (groups): Efinopegdutide (experimental) and Placebo (placebo comparator).

Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.

The registry classes the interventions as combination product.

Who Took Part

85 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH). Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: has history of a liver disease other than mash, for example, hepatitis b or c, drug-induced liver disease, or autoimmune liver disease; has history of type 1 diabetes; had a bariatric surgical procedure less than 5 years before entry into the study.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Efinopegdutide and who got the comparison, which limits bias.

The Efinopegdutide group and the comparison group ran side by side rather than switching.

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Efinopegdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-07-12 with completion listed for 2026-08-03.

It ran at 68 sites in United States (33), Spain (8), France (5), Israel (5), Japan (5) and Australia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in Liver Fat Content (LFC) at Week 28 (time frame: Baseline and 28 weeks). Percentage of Participants Who Experienced an Adverse Event (AE) (time frame: Up to approximately 36 weeks). Percentage of Participants Discontinuing Study Medication Due to an AE (time frame: Up to approximately 28 weeks).

It also tracked 6 secondary outcomes, for example Change from Baseline in Iron-corrected T1 (cT1) at Week 28, Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28, Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28, Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28, Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28 and Percent Change from Baseline in Body Weight at Week 28.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Efinopegdutide in 85 people with fatty liver & elevated liver enzymes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Efinopegdutide compound page, Fatty liver & elevated liver enzymes research.