Status:
COMPLETED
Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Wellcome Trust
Novo Nordisk A/S
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 par...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01237119
Start Date
August 1 2010
End Date
July 1 2014
Last Update
March 23 2016
Active Locations (1)
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1
NIHR BRU Centre for liver research, Queens Elizabeth University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B152TT