Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study

What Was Tested

Researchers studied Liraglutide in this randomized controlled trial publication.

Who Took Part

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Patients were randomly assigned (1:1) using a computer-generated, centrally administered procedure, stratified by trial centre and diabetes status.

Patients, investigators, clinical trial site staff, and pathologists were masked to treatment assignment throughout the study.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Some participants received a placebo instead of Liraglutide, giving a reference point.

More than one site took part, so the participants came from several places.

The primary outcome measure was resolution of definite non-alcoholic steatohepatitis with no worsening in fibrosis from baseline to end of treatment (48 weeks), as assessed centrally by two independent pathologists.

Analysis was done by intention-to-treat analysis, which included all patients who underwent end-of-treatment biopsy.

The trial was registered with ClinicalTrials.gov, number NCT01237119.

What Was Measured

Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Incretins, Liraglutide and Non-alcoholic Fatty Liver Disease.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2016 (Lancet (London, England)), a journal based in England.

More context: the Liraglutide compound page.