Browse by author
Lookup NU author(s): Dr Deborah Stocken
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
Introduction Non-alcoholic steatohepatitis (NASH) is now the commonest cause of chronic liver disease. Despite this, there are no universally accepted pharmacological therapies for NASH. Liraglutide (Victoza), a human glucagon-like peptide-1 (GLP-1) analogue, has been shown to improve weight loss, glycaemic control and liver enzymes in type 2 diabetes. There is currently a lack of prospective-controlled studies investigating the efficacy of GLP-1 analogues in patients with NASH. Methods and analysis Liraglutide efficacy and action in NASH (LEAN) is a phase II, multicentre, double-blinded, placebo-controlled, randomised clinical trial designed to investigate whether a 48-week treatment with 1.8mg liraglutide will result in improvements in liver histology in patients with NASH. Adult, overweight (body mass index 25kg/m(2)) patients with biopsy-confirmed NASH were assessed for eligibility at five recruitment centres in the UK. Patients who satisfied the eligibility criteria were randomly assigned (1:1) to receive once-daily subcutaneous injections of either 1.8mg liraglutide or liraglutide-placebo (control). Using A'Hern's single stage phase II methodology (significance level 0.05; power 0.90) and accounting for an estimated 20% withdrawal rate, a minimum of 25 patients were randomised to each treatment group. The primary outcome measure will be centrally assessed using an intention-to-treat analysis of the proportion of evaluable patients achieving an improvement in liver histology between liver biopsies at baseline and after 48weeks of treatment. Histological improvement will be defined as a combination of the disappearance of active NASH and no worsening in fibrosis. Ethics and dissemination The protocol was approved by the National Research Ethics Service (East MidlandsNorthampton committee; 10/H0402/32) and the Medicines and Healthcare products Regulatory Agency. Recruitment into the LEAN started in August 2010 and ended in May 2013, with 52 patients randomised. The treatment follow-up of LEAN participants is currently ongoing and is due to finish in July 2014. The findings of this trial will be disseminated through peer-reviewed publications and international presentations.
Author(s): Armstrong MJ, Barton D, Gaunt P, Hull D, Guo K, Stocken D, Gough SCL, Tomlinson JW, Brown RM, Hubscher SG, Newsome PN, LEAN Trial Team
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2013
Volume: 3
Issue: 11
Pages: 1-15
Print publication date: 04/11/2013
ISSN (print): 2044-6055
ISSN (electronic):
Publisher: BMJ Publishing Group
URL: http://dx.doi.org/10.1136/bmjopen-2013-003995
DOI: 10.1136/bmjopen-2013-003995
Altmetrics provided by Altmetric
