Clinical Research Directory

Inclusion Criteria: Adult individuals, age \> 18 years * NAFLD with fibrosis score \>2 according to the Steatosis Activity and Fibrosis score, but no cirrhosis histological diagnosis according to the SAF fibrosis score on a liver biopsy performed \< 6 months before screening in the study and confirmed by central reading during the screening period. * Individuals agrees to have a liver biopsy performed after the treatment * Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol: * ALAT \<10x ULN * Hemoglobin \> 11g/dL for females and 12 g/dL for males * White blood cell (WBC) \> 2.5 K/ μL * Neutrophil count \> 1.5 K μL * Platelets \> 100 K/μL * Total bilirubin \<35 μmol/L * Albumin \>30 g/L * TP \>80% or INR \<1.4 * Serum creatinine \<1.3 mg/dL (men) or \<1.1 mg/dL (women) or estimated glomerular filtration rate (eGFR) \> 60mL/min/1.73m2 * Have a stable weight since the liver biopsy was performed defined by no more than a 5% loss of initial body weight * Subjects should be able to give informed consent Exclusion Criteria: * Evidence of another form of liver disease * History of sustained excess alcohol ingestion: daily consumption \>30g/day (3 drinks per day) for males and \>20 g/day (2 drinks per day) for females * Unstable metabolic condition: weight change \> 5 kg in the last three months, diabetes with poor glycaemic control (HbA1c \> 8.5%), introduction of an antidiabetic or of an anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the past 6 months prior to screening * Bariatric surgery * ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose oestrogens, methotrexate, tetracycline or amiodarone in the previous 6 months * Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, active malignancy, compromised immunity * Pregnancy/lactation or inability to adhere to adequate contraception in woman of childbearing potential * Body mass index (BMI) \>45 kg/m2 * Type 1 diabetes * Haemostasis disorders or current treatment with anticoagulants * Contra-indication to liver biopsy * History of/or current cardiac dysrhythmias and/or a history of cardiovascular disease event, including myocardial infarction, except patients with only well controlled hypertension * QTc \>450 msec on ECG * Use of prescribed drugs dependent on CYP3A4 with narrow therapeutic window and strong inducers or inhibitors of CYP3A4 * Use of H2-antagonists and/or Proton Pump Inhibitors