study to investigate the effects of different doses of s-adenosyl-l-methionine (same) in subjects with nonalcoholic fatty liver disease and non-treated matched healthy volunteers as control group

Conditions: Non Alcoholic Fatty Liver Disease

Summary: investigation the effects of different doses of same in subjects with nonalcoholic fatty liver disease and non-treated matched healthy volunteers as control group


Eligibility criteria:
inclusion criteria * subjects with non-alcoholic steatohepatitis based on histology in medical history within the last 3 years * subjects in a stable metabolic condition since histology for nash (non-alcoholic steatohepatitis) exclusion criteria * subjects with extrahepatic biliary obstruction * subjects with primary sclerosing cholangitis (psc) * subjects with primary biliary cirrhosis (pbc) * any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years * history of active substance abuse (oral, inhaled or injected) within one year prior to the study * subjects with renal impairment (creatinine level of \>2.0 mg/dl) * subjects with a known hypersensitivity to the active substance (ademetionine) or methionine or to any of the inactive ingredients * subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, vitamin b12 metabolism defect) * subjects on total parenteral nutrition in the year prior to screening * subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery) * extrahepatic cholestasis (proven by ultrasound) * subjects with alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \> 5 upper limit of normal (uln) * subject with serum total bilirubin (stb) \> 5 uln * subjects after liver transplantation and subjects on the waiting list for liver transplantation * subjects with any of the following disease in medical history: * viral hepatitis (serum positive hbcab (hepatitis b core antibody) or hepatitis c virus (hcv) ribonucleic acid (rna) * evidence of autoimmune liver disease * wilson's disease * hemochromatosis * alpha-1-antitrypsin deficiency * known positivity for antibody to human immunodeficiency virus (hiv) * known heart failure of new york heart association class 3 or 4 * current or history of significant alcohol consumption for a period of more than three consecutive months within five years prior to screening (significant alcohol consumption is defined as \> 3 u (unit)/day for men and \> 2 u/day for women, on average) or binge drinking or inability to reliably quantify alcohol consumption. * clinical or histological evidence of cirrhosis f4 * subjects with history of biliary diversion * subjects with uncontrolled diabetes mellitus defined by hba1c (hemoglobin a1c) \> 8.0 % at screening * concomitant medication of b12, folate, betaine or choline * concomitant treatment with glitazone within the past year prior to the study * subjects with known folate or b12 deficiency * bmi (body mass index) \> 40 kg/m2 * history of major depression diagnostic and statistical manual of mental disorders (dsm-iv) or bipolar disease * women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study. * breastfeeding women * any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study * investigational drug intake within one month prior to the study * active, serious medical disease with likely life-expectancy less than five years * uncooperative attitude or reasonable likelihood for non-compliance with the protocol or any other reason that, in the investigator's opinion, prohibits the inclusion of the subject into the study * legal incapacity or limited legal capacity, or who are incarcerated. * inability to return for scheduled visits. * inability to understand and follow the requirements of the protocol in the local language

Keywords: steatohepatitis