Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease

What Was Tested

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

INTERVENTION PROGRAM: All subjects underwent dietary control and exercise therapy, and controlled smoking and alcohol consumption.

During the 3 months of the trial, men were instructed to follow a diet of 1,500 to 1,800 kcal per day and women followed a diet of 1,200 to 1,500 kcal per day.

It had three arms (groups): lifestyle intervention + orlistat group (active comparator), lifestyle intervention + liraglutide group (experimental) and lifestyle intervention + liraglutide + orlistat group (experimental).

The control group was treated with lifestyle intervention + orlistat until the end of follow-up.

Trial group 1 was treated with lifestyle intervention + liraglutide.

Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months.

The registry classes the interventions as drug.

More on the Plan

The ratio of test group 1,2 and control group was 1:1:1. 2.

Who Took Part

102 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Clinical diagnosis of Metabolic Associated Fatty Liver Disease(MAFLD);. Clinical diagnosis of Obesity.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: medicated hepatitis and viral hepatitis;; have severe hepatic or renal insufficiency;; have used any weight-loss drug;.

How the Study Was Run

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

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

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Liraglutide.

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

It started in 2023-11-01 with completion listed for 2024-10-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body weight (time frame: Three months). FABP4 (time frame: Three months). BMI (time frame: Three months).

It also tracked 2 secondary outcomes, for example Waist circumference, and hip circumference.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 102 people with fatty liver & elevated liver enzymes.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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