A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

What Was Tested

This registered phase 2 trial tested Semaglutide for fatty liver & elevated liver enzymes.

Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance.

The study will last for about 61 weeks in total.

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

Semaglutide placebo once-weekly.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 71 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. A histological NAFLD activity score (NAS) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation. Body mass index equal to or above 27 kg/m\^2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation; presence or history of hepatocellular carcinoma; treatment with glucagon-like peptide-1 receptor agonists (glp-1 ras) in the period from 90 days prior to screening.

How the Study Was Run

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

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Semaglutide.

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

It started in 2019-06-18 with completion listed for 2021-04-22.

It ran at 38 sites in United States (24), France (5), United Kingdom (4), Germany (3) and Spain (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 47 secondary outcomes, for example Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline, Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline, Percentage of Participants With NASH Resolution After 48 Weeks, Change From Baseline in Fibrosis-4 Score-Ratio to Baseline, Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) and Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 71 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, Fatty liver & elevated liver enzymes research.