Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis (LEAN)
The purpose of this study is to investigate whether 48 weeks treatment with once-daily injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough to warrant further investigation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||48-week Phase II, Randomised, Double Blinded Placebo Controlled Multicentre Trial on Liraglutide's Safety, Efficacy and Action on Liver Histology and Metabolism in Overweight Patients With NASH +/- Type II Diabetes|
- Liver Histological improvement [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- NAFLD Activity Score [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Fibrosis panel, Liver Function Tests (LFTs), cytokeratin-18 (CK-18) Glycaemic control, Fibroscan, Quality of life
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
A once-daily glucagon-like peptide 1 (GLP-1) analogue. Currently has regulation approval for use in type 2 diabetics (ref: guidelines)
1.8 mg once daily, subcutaneous injection
Other Name: Victoza
Placebo Comparator: Placebo
Liraglutide-Placebo manufactured by Novo Nordisk.
1.8 mg once-daily, subcutaneous injection
Non-alcoholic fatty liver disease (NAFLD) is responsible for an increasing prevalence of liver disease and is becoming the commonest cause of liver disease in the western world. 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.
Current treatment options for NASH are limited in efficacy, necessitating the development of more effective options. New agents such as Glucagon-like Peptide-1 (GLP-1) agonists that improve diabetic control and facilitate weight loss have been suggested as therapies in NASH.
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. This study hypothesises that treatment with liraglutide will result in a significant improvement in histological disease activity in overweight patients with NASH, in the presence or absence of Type 2 Diabetes (T2DM)
|NIHR BRU Centre for liver research, Queens Elizabeth University Hospital Birmingham|
|Birmingham, West Midlands, United Kingdom, B152TT|
|Principal Investigator:||Philip N Newsome, FRCPE PhD||Centre for liver research, University of Birmingham|