Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had six arms (groups): one (experimental), one (experimental), one (experimental), Placebo 1 (placebo comparator) and Placebo 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 320 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the 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 and investigator.

It started in 2016-11-30 with completion listed for 2020-02-13.

It ran at 158 sites in United States (39), Russia (26), United Kingdom (16), Japan (15), France (11) and Canada (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) (time frame: After 72 weeks).

It also tracked 87 secondary outcomes, for example Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS), Percentage of Participants With Change in Steatosis, Percentage of Participants With Change in Lobular Inflammation, Percentage of Participants With Change in Hepatocyte Ballooning, Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification and Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 320 people.

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

More context: the Semaglutide compound page, all human trials.