Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

It had four arms (groups): SEMA + CILO/FIR FDC (experimental), SEMA + PTM CILO/FIR (experimental), PTM SEMA + CILO/FIR FDC (experimental) and PTM SEMA + PTM CILO/FIR (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

457 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Screening laboratory parameters as determined by the study central laboratory:. International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation. Platelet count ≥ 125,000/µL. Alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN). Serum alkaline phosphatase (ALP) ≤ 2 x ULN.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: prior history of decompensated liver disease, including ascites, hepatic encephalopathy (he), or variceal bleeding; child-pugh (cp) score \> 6 at screening, unless due to an alternative etiology such as gilbert's syndrome or therapeutic anticoagulation; model for end-stage liver disease (meld) score \> 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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 2021-08-09 with completion listed for 2024-11-12.

It ran at 242 sites in United States (175), France (18), Spain (16), Japan (12), Canada (11) and Australia (7).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 457 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.