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Trial · Interventional

CompletedPhase 2Registry data

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

Short name LEAN

NCTNCT01237119 (opens ClinicalTrials.gov in a new tab)Other idHE2013Other idISRCTN85774727

Overview

Status
Completed
Phase
Phase 2
Enrollment
52 participants (actual)
Sponsor
University of Birmingham · Other
Design
Randomized · Quadruple masking
Countries
1 country

United Kingdom

Start
Aug 2010
Primary completion
Jul 2014
Completion
Jul 2014
First posted
9 Nov 2010 (estimated)
Last update posted
23 Mar 2016 (estimated)
Conditions
Nonalcoholic Steatohepatitis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012201320142015
  1. Ph 2

    LEAN

    NCT01237119

    Aug 2010 to Jul 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • Liraglutide-placeboOther

Arms2

  • Experimental

    Liraglutide

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

  • Placebo comparator

    Placebo

    Liraglutide-Placebo manufactured by Novo Nordisk.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Liver Histological improvement

    Time frame · 48 weeks

Secondary outcomes(1)
  1. NAFLD Activity Score

    Time frame · 48 weeks

    Registry description

    Also including: Fibrosis panel, Liver Function Tests (LFTs), cytokeratin-18 (CK-18) Glycaemic control, Fibroscan, Quality of life

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

12 results

Glucagon-like peptide 1 decreases lipotoxicity in non-alcoholic steatohepatitis.

Armstrong et al. 2016Journal of hepatologycited by 354

PMID 26394161PMC4713865DOI 10.1016/j.jhep.2015.08.038PUB-26394161

CC BY12 results

Indexing hint: Randomized controlled trial · 2016

7 results

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

Armstrong et al. 2016Lancet (London, England)cited by 1,668

PMID 26608256DOI 10.1016/s0140-6736(15)00803-xPUB-26608256

Rights unknown7 results

More studies

1 study on this page

PubMed tag: none · 2013

Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial.

Armstrong et al. 2013BMJ opencited by 38

PMID 24189085PMC3822302DOI 10.1136/bmjopen-2013-003995PUB-24189085

CC BY
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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria (brief): * Insulin dependent diabetes * Glycosylated Haemoglobin (HbA1c) \> 9.0% * treatment with dipeptidyl peptidase 4 (DPP-IV) inhibitors, Glucagon-like Peptides (GLP) 1 analogues, thiazolidinediones (TZDs) * Past Medical History of Acute (or chronic) pancreatitis/pancreatic carcinoma, weight loss surgery, liver transplantation, Medullary thyroid cancer, hepatocellular carcinoma (HCC), Multiple Endocrine Neoplasia (MEN) syndrome, malignancy (within last 3 years, exception of treated skin malignancy) * 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) * concomitant or recent use of orlistat, prednisolone, * Refusal or lacks capacity to give informed consent to participate in the trial * Participation in any clinical trial of an investigational therapy or agent within 3 months of randomisation * Patient (or carer) deemed not competent at using the correct site and technique for subcutaneous injection of the trial treatment (containing dummy drug on practice) at visit 2 * NAS\<3 * Child's B or C cirrhosis * Abnormal clinical examination of thyroid (i.e. unexplained goitre or palpable nodules) * Liver enzymes \> 10 x upper limit of normal * Average alcohol consumption per week \> 21 units (210g) male, \>14 units (140g) female within the last 5 years. * \>5% weight loss since the diagnostic liver biopsy was obtained. * Recent or concomitant use of steroids (oral), methotrexate, amiodarone, Orlistat * Addition or significant change (as judged by the chief investigator) in dose of the following drugs; Angiotensin converting enzymes (ACE)-inhibitors, Angiotensin receptor blockers (ARBs) and/or Multi-vitamins (containing Vitamin E) * Known positivity for antibody to Human Immunodeficiency virus (HIV) * Serum creatinine \> 150 μmol/L or currently being treated with renal replacement therapy * Past medical history of multiple drug allergies (defined as anaphylactoid drug reactions in \>2 drug groups) * Presence of any acute/chronic infections or illness that at the discretion of the chief investigator might compromise the patient's health and safety in the trial * Pregnancy or breastfeeding * Women, of child-bearing age, who are not willing to practise effective contraception (i.e. barrier, oral contraceptive pill, implanon or history hysterectomy) for the 48 week duration of the trial and for one-month after the last administration of the drug. * Men, sexually active with women of child-bearing age, who are not willing to practise effective contraception for the 48 week duration of the trial and for one-month after the last administration of the drug.

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