A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver

What Was Tested

The trial (phase 1) is built around Semaglutide for fatty liver & elevated liver enzymes.

This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver disease.This study is comparing the change in early stages of scar tissue in the liver and fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine).

Participants will either get semaglutide or placebo; which treatment participants get is decided by chance.

Semaglutide is a medicine under clinical investigation.

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

The registry classes the interventions as drug.

Who Took Part

67 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. Liver stiffness between 2.50 and 4.63 kPa (both inclusive) measured by magnetic resonance elastography at screening. Body mass index between 25.0 and 40.0 kg/sqm (both inclusive) at the screening visit.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes according to medical records; history or presence of pancreatitis (acute or chronic) as declared by the subject; screening calcitonin greater than or equal to 100 ng/l.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-11-28 with completion listed for 2020-03-20.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) (time frame: Up to day -20, week 48).

It also tracked 30 secondary outcomes, for example Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE), Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE), Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF), Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF), Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) and Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 67 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, Fatty liver & elevated liver enzymes research.