Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide for fatty liver & elevated liver enzymes.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Development of efficient screening strategies for the identification and treatment of individuals who are at greatest risk for advanced disease in this population is an urgent and unmet medical need.

Type 2 diabetes mellitus (T2DM) and obesity are critical risk factors for advanced NAFLD.

Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that is FDA-approved for the treatment of obesity (as Wegovy) or T2DM (as Ozempic), conditions that are considered major risk factors for advanced fibrosis in the NAFLD population.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 40 years up to 79 years.

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

Examples of who could join: Adult, age ≥ 40 and \< 80 years. Participant must meet at least one of following sets of conditions:. BMI ≥ 27 kg/m² OR. BMI ≥ 25 kg/m² AND presence of i) pre-diabetes (HbA1C ≥ 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations. The subject is fully informed and willing and able to perform all the procedures specified in the protocol and has signed a written informed consent to participate.

The full record lists 10 inclusion and 18 exclusion criteria; among the exclusions: VCTE ≥ 20 kPa; platelet count ≤ 140,000 per ml; INR \> 1.35, unless on coumadin for another indication.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2023-07-25 with completion listed for 2026-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in fibrosis due to NAFLD (time frame: 52 weeks).

It also tracked 3 secondary outcomes, for example Change in liver stiffness, Change in steatosis and Change in ALT.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 120 people with fatty liver & elevated liver enzymes.

Its status is active not recruiting; 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.