Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

What Was Tested

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

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

It had five arms (groups): Semaglutide (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 109 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: Screening laboratory parameters, as determined by central laboratory:. Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN). Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation. International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy. Platelet count ≥ 100,000/μL.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: any historical liver biopsy consistent with cirrhosis; any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding; history of liver transplantation.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2019-07-29 with completion listed for 2020-07-13.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs). Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 109 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.