Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

What Was Tested

This registered phase 2 trial tested Semaglutide for fatty liver & elevated liver enzymes and insulin resistance, prediabetes & type 2 diabetes.

The purpose of this study was to evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

This study evaluated the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis.

All participants received semaglutide subcutaneously once weekly for 24 weeks, followed by 24 weeks of observation off of the study drug.

IHTG was quantified by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) evaluations at two time points during the study.

Participants attended several study visits through Week 48.

Who Took Part

The registry lists 51 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: No change in antiretroviral therapy (ART) in the 24 weeks prior to entry. NOTE B: Within-class substitutions are not permitted. No plan to change ART for the study duration. Within 30 days prior to pre-entry, a minimum WC measurement of ≥95 cm for individuals assigned male sex at birth or ≥94 cm for individuals assigned female sex at birth. NOTE: For transgender study participants, sites should use the parameter that matches sex assigned at birth.

The full record lists 47 inclusion and 42 exclusion criteria; among the exclusions: known active hepatitis c virus (hcv) infection, defined as a detectable hcv rna within 24 weeks prior to study entry; active/chronic hepatitis b (hbv), defined as a positive hepatitis b surface antigen (hbsag) at screening; NOTE B: If HBsAg positive, individual is not eligible and should be referred for clinical evaluation through routine care.

How the Study Was Run

The set-up was single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-02-19 with completion listed for 2023-03-16.

It ran at 9 sites in United States (8) and Brazil (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change (Absolute) in IHTG (%) (time frame: Measured at pre-entry and Week 24).

It also tracked 24 secondary outcomes, for example Change (Percent) in IHTG (%), Level of IHTG (%), Occurrence of Premature Discontinuation of Study Treatment, Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment, Change (Absolute) in Body Mass Index (BMI) and Change (Absolute) in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Semaglutide in 51 people with fatty liver & elevated liver enzymes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, Fatty liver & elevated liver enzymes research, Insulin resistance, prediabetes & type 2 diabetes research.