Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide for fatty liver & elevated liver enzymes and insulin resistance, prediabetes & type 2 diabetes.

It had three arms (groups): Liraglutide (experimental), Bariatric Surgery (active comparator) and Diet modification and exercise (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Diet and exercise produce a modest effect on NASH which is limited by weight regain, even with intensive lifestyle modification.

Bariatric surgery produces the greatest amount of weight loss, but is less acceptable to many patients than lifestyle modification or medical therapy, and is limited by cost and complications, particularly post-surgical malabsorption and potential psychological complications.

Liraglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue which is indicated for treatment of type 2 diabetes in adults.

However, there is little information on the effects of GLP-1 analogues on NASH, particularly in comparison to other modalities of weight loss such as surgery.

Who Took Part

36 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index \> 27.5 kg/m2. Waist circumference (WC) \> 90 cm (male) or \> 80 cm (female). Diagnosis of NASH based on Liver Function Test Results ,Ultrasound Hepato-Biliary System (HBS) findings and / or Liver Biopsy.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: hepatitis b or c carrier, liver disease other than nafld; history of pancreatitis; personal or family history of multiple endocrine neoplasia type 2 or thyroid carcinoma.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

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

It started in 2014-03 with completion listed for 2017-12.

It ran at 1 site in Singapore.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Liraglutide in 36 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

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, Insulin resistance, prediabetes & type 2 diabetes research.