Semaglutide in Nonalcoholic Fatty Liver Disease

What Was Tested

The trial (phase 4) is built around Semaglutide for fatty liver & elevated liver enzymes.

The goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus.

Participants will undergo: * Abdominal ultrasound. * Fibroscan with controlled attenuation parameter to assess liver stiffness (kPa) and liver steatosis (dB/m). * Fibrosis-4 score requires values of age, alanine aminotransferase, aspartate aminotransferase, and platelet count. * NAFLD Fibrosis Score requires values of age, BMI, platelet count, albumin, hyperglycemia, and ALT/AST ratio.

It had three arms (groups): NAFLD1 (active comparator), NAFLD2 (active comparator) and NAFLD3 (active comparator).

Hepatic steatosis.

Hepatic steatosis.

Hepatic steatosis.

The registry classes the interventions as drug.

More on the Plan

Rationale: NAFLD is one of the major causes of chronic liver disease worldwide with the highest prevalence in Middle East countries.

Aim of the study: To determine the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus.

Objectives: * Determine the therapeutic effect of oral and SC Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. * Compare oral and SC forms of Semaglutide. * Evaluate the impact of the medication on glycemic control and weight loss.

Type of study: This study is an open-label clinical trial. 3.

Who Took Part

Enrollment: 180 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: Primary obesity with body mass index (BMI) \> 30. Type 2 diabetes mellitus.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: type 1 diabetes mellitus; DM, which is treated with insulin glargine; alcohol consumption.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-02-15 with completion listed for 2024-02-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): NAFLD regression (time frame: 48 weeks).

It also tracked 1 secondary outcome, for example Fibrosis regression.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 180 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.