Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

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

A once-daily glucagon-like peptide 1 (GLP-1) analogue. Currently has regulation approval for use in type 2 diabetics (ref: guidelines).

The registry classes the interventions as drug and other.

More on the Plan

NAFLD is recognised to be the hepatic manifestation of the metabolic syndrome, which is a cluster of metabolic abnormalities characterised by abdominal obesity, insulin resistance, impaired glucose metabolism, hypertension and dyslipidaemia.

In its mildest form there is an accumulation of fat in the liver (steatosis) without any liver damage, however in many cases it progresses to non-alcoholic steatohepatitis (NASH), and cirrhosis.

No published studies to date have assessed the impact of the GLP-1 agonist, Liraglutide, on liver histology and metabolism in obese patients with NASH.

Who Took Part

Enrollment: 52 actual participants took part.

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: NASH on liver biopsy (within 6 months of screening visit). NAFLD Activity Score (NAS) ≥ 3, comprising of a minimum of 1 point from each of the individual steatosis, lobular inflammation and hepatocyte ballooning scores. Body Mass Index (BMI) ≥ 25 at randomisation. Type 2 Diabetes Mellitus/impaired glucose tolerance or normal glucose tolerance.

The full record lists 4 inclusion and 24 exclusion criteria; among the exclusions: insulin dependent diabetes; treatment with dipeptidyl peptidase 4 (dpp-iv) inhibitors, glucagon-like peptides (glp) 1 analogues, thiazolidinediones (tzds); other liver aetiologies (i.e. drug-induced, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, haemochromatosis, alpha 1 anti-trypsin deficiency, wilsons disease).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

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

It started in 2010-08 with completion listed for 2014-07.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example NAFLD Activity Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 52 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.