Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

What Was Tested

The trial (phase 2) is built around Semaglutide.

NNC0194-0499 is a new medicine which works in the liver.

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

It had ten arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

The registry classes the interventions as drug.

Who Took Part

698 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: documented causes of chronic liver disease other than 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 more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at v2a.

How the Study Was Run

The set-up was 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.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2021-08-31 with completion listed for 2024-12-17.

It ran at 255 sites in United States (70), Russia (32), India (18), Japan (17), Poland (11) and Australia (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No), Change in histology-assessed liver collagen proportionate area, Progression of liver fibrosis (Yes/No), Worsening in steatohepatitis (Yes/No), Change in ALT (alanine aminotransferase) and Change in AST (aspartate aminotransferase).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 698 people.

With 698 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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