Combined Active Treatment in Type 2 Diabetes With NASH

What Was Tested

This registered phase 4 trial tested Semaglutide for fatty liver & elevated liver enzymes.

It had three arms (groups): Combined treatment with Empagliflozin and Semaglutide (experimental), Empagliflozin monotherapy (experimental) and Placebo (placebo comparator).

Placebo matching Empagliflozin (film-coated tablet, once daily) and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly).

The registry classes the interventions as drug.

More on the Plan

In addition, people with NASH are at an excessive risk of cardiovascular morbidity and mortality.

Who Took Part

Enrollment: 192 actual participants took part.

It was open to people of any sex aged from 25 years up to 75 years.

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

Examples of who could join: Diagnosis of T2D and NASH with fibrosis stage F1-F3. Age between 25 and 75 years. Obtained written informed consent.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: contraindications on liver biopsy; evidence of cirrhosis on liver biopsy; history of ketoacidosis.

How the Study Was Run

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

The fatty liver & elevated liver enzymes 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.

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

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

It started in 2021-03-26 with completion listed for 2025-01-31.

It ran at 26 sites in Germany (21) and Austria (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Histological resolution of NASH without worsening of fibrosis (time frame: from baseline to 48 weeks).

It also tracked 4 secondary outcomes, for example Overall NAFLD activity score (NAS), Stage of fibrosis according to the Kleiner Fibrosis Classification, Activity component of NASH according to the steatosis-activity-fibrosis (SAF) score and Hepatic steatosis grade.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 192 people with fatty liver & elevated liver enzymes.

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

More context: the Semaglutide compound page, Fatty liver & elevated liver enzymes research.