A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

What Was Tested

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

It had two arms (groups): Efinopegdutide (experimental) and Semaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 145 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening. Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive). Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive).

The full record lists 7 inclusion and 22 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus (t1dm), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy; ongoing, inadequately controlled hypothyroidism or hyperthyroidism; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2021-08-04 with completion listed for 2022-10-19.

It ran at 69 sites in United States (9), Israel (6), Turkey (Türkiye) (6), Italy (5), Mexico (5) and South Korea (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants Who Experienced an Adverse Event (AE) (time frame: Up to ~29 weeks). Percentage of Participants Who Discontinued Study Intervention Due to an AE (time frame: Up to ~24 weeks).

It also tracked 8 secondary outcomes, for example Mean Percent Change From Baseline in Body Weight After 24 Weeks, Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks, Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks, Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks, Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks and Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Efinopegdutide in 145 people with fatty liver & elevated liver enzymes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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