A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide and Efinopegdutide for fatty liver & elevated liver enzymes.

The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Placebo (placebo comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 381 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: Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of liver disease other than nash; history or evidence of cirrhosis; history of pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-06-23 with completion listed for 2025-12-29.

It ran at 175 sites in United States (42), Japan (21), France (10), Spain (10), China (9) and Mexico (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52 (time frame: Week 52). Percentage of Participants Who Experienced an Adverse Event (AE) (time frame: Up to 60 weeks). Percentage of Participants Discontinuing Study Medication Due to an AE (time frame: Up to 52 weeks).

It also tracked 2 secondary outcomes, for example Change from Baseline in Body Weight At Week 52.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Efinopegdutide in 381 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 Semaglutide compound page and the Efinopegdutide compound page, Fatty liver & elevated liver enzymes research.