Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

What Was Tested

This registered phase 3 trial tested Semaglutide.

Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

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

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

Semaglutide administrated subcutaneously once weekly.

Placebo administrated subcutaneously once weekly.

The registry classes the interventions as drug.

Who Took Part

1205 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age above or equal to 18 years at the time of signing informed consent. Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: documented causes of chronic liver disease other than non-alcoholic fatty liver disease (nafld); positive hbsag, positive anti-hiv, positive hcv rna at screening (v2a) or any known presence of hcv rna or hbsag within 2 years of screening (v2a); presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2021-04-01 with completion listed for 2029-04-25.

It ran at 558 sites in United States (130), Japan (59), China (41), United Kingdom (26), India (19) and Turkey (Türkiye) (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) (time frame: From randomisation (week 0) to week 72). Part 2: Cirrhosis-free survival (Yes/No) (time frame: From randomisation (week 0) to week 240).

It also tracked 35 secondary outcomes, for example Change in body weight, Change in SF-36 (Short Form 36) Bodily Pain, Change in body weight, Change in histology-assessed liver collagen proportionate area, Worsening in steatohepatitis (Yes/No) and Progression of liver fibrosis in patients with F2 at baseline (Yes/No).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1205 people.

With 1205 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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