Non-alcoholic steatohepatitis (NASH)
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Liraglutide
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
University of Oxford, Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-diabetic (HbA1c 7 days apart and or Historical liver biopsy showing NASH and/or =F1 fibrosis or NFS = -1.455 OR Fib-4 = 1.3 OR Fibroscan =8kPa. Non-pregnant, not planning pregnancy BP10% within the preceding 3 months Normal renal function No contraindications to Lifestyle or Liraglutide Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Age 75years • Body mass index 40kg/m2 • A diagnosis of diabetes (type 1 or type 2) • Use of anti-diabetic or weight loss medications or a GLP-1 agonist such as Liraglutide) • Contra-indication to Liraglutide • A blood haemoglobin 21 drinks on average per week for men and > 14 drinks on average per week for women • Pregnant or nursing mothers • History of severe claustrophobia • Presence of metallic implants, pacemaker that are contra-indications to MRI scanning • Haemorrhagic disorders • Anticoagulant treatment • Other co-morbidities that in the eyes of the investigators may affect data collection • A medical condition in the opinion of the investigator that might impact upon safety or validity of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if treatment with Liraglutide improves liver fat and inflammation (non-alcoholic steatohepatitis, NASH), more than matched weight loss alone;Secondary Objective: Investigate changes in: 1. the rate of hepatic de-novo lipogenesis (new fat generation and deposition in the liver) 2. circulating liver transaminases (liver function markers in the blood) 3. liver and peripheral insulin sensitivity and glucose disposal (metabolism) 4. adipose (fat) tissue insulin sensitivity 5. whole body fat oxidation 6. weight and BMI 7. body fat and muscle composition ;Primary end point(s): Hepatic fat and inflammation measured using multi-parametric MR imaging (abdominal MRI);Timepoint(s) of evaluation of this end point: 12 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in rate of hepatic de-novo lipogenesis. Change in circulating liver transaminases. Change in hepatic and peripheral insulin sensitivity and glucose disposal. Change in adipose tissue insulin sensitivity. Change in whole body oxidation. Change in weight. Change in body composition. Change in urinary markers of liver disease. Change in faecal markers of liver disease.;Timepoint(s) of evaluation of this end point: 12 and 24 weeks | — |
Countries
United Kingdom
Contacts
Public ContactCTRG (via Heather House)
University of Oxford, Clinical Trials and Research Governance
Outcome results
None listed