Semaglutide combined with empagliflozin vs. monotherapy for non-alcoholic fatty liver disease in type 2 diabetes: Study protocol for a randomized clinical trial

What Was Tested

This clinical study looks at Semaglutide in the context of fatty liver & elevated liver enzymes.

Lifestyle intervention remains a preferred treatment modality for NAFLD.

This study has been registered with Chinese Clinical Trial Registry (ChiCTR2300070674).

Who Took Part

The study group was 2 patients.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

This 52-week double-blinded, randomised, parallel-group, active-controlled trial evaluates the effects of semaglutide, empagliflozin and semaglutide + empagliflozin in 105 eligible overweight/obese subjects with NAFLD and T2DM.

Secondary endpoints include changes in liver stiffness measurement, liver enzymes, blood glucose, lipid levels, renal function, electrolyte balances, minerals and bone metabolism, cytokines, high-sensitivity C-reactive protein, ferritin, anthropometric indicators, nonalcoholic fatty liver fibrosis score, fibrosis 4 score and homeostatic model assessment for insulin resistance.

How the Study Was Run

In design terms this was a randomized, double-blind and parallel-group study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

The primary outcome will be a change from baseline to week 52 in the controlled attenuation parameter, free fatty acid and glucagon.

In addition, intention-to-treat, interim analysis and safety analysis will be performed.

What Was Measured

Topics PubMed links to this paper include Benzhydryl Compounds, Blood Glucose, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Glucosides, Hypoglycemic Agents and Non-alcoholic Fatty Liver Disease.

What This Means in Plain Language

The paper is a randomized, double-blind and parallel-group study of Semaglutide in 2 patients in people with fatty liver & elevated liver enzymes.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2024 (PloS one), a journal based in United States.

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