reducing non-alcoholic steatohepatitis

Conditions: Non-alcoholic Steatohepatitis; Liver Diseases; Diabetes Mellitus, Type 2; Fibrosis, Liver

Summary: the goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. the objectives are: primary objective to evaluate the change in histological grading and staging of nash in patients with confirmed non-alcoholic steatohepatitis (nash) treated with empagliflozin for a duration of 48 weeks. secondary objective to evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration. participants will: take empagliflozin every day for 12 months. visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).


Eligibility criteria:
inclusion criteria: * ability and eligibility to provide informed consent. * age between 18 and 75 years at the time of study initiation. * confirmed or excluded diagnosis of type 2 diabetes mellitus (dm2) according to the target group (ogtt test, hba1c). * diagnosis of nash confirmed by a central pathologist based on histological evaluation of a liver biopsy performed within 3 months prior to the initiation of the investigational drug. - the evaluation must include determination of the process activity according to the nafld activity score (nas). * hba1c value ≤ 80 mmol/mol. * for women of childbearing potential, willingness to use at least two adequate methods of contraception. exclusion criteria: * contraindication to liver biopsy. * documented episode of ketoacidosis. * contraindication or hypersensitivity to empagliflozin. * presence of acute or chronic illness that, in the investigator's opinion, could jeopardize the health or safety of the patient. * hba1c value \> 80 mmol/mol. * inability to safely discontinue thiazolidinedione (pioglitazone) therapy. * liver disease of other etiologies, including viral hepatitis b and c, autoimmune hepatitis, alpha-1 antitrypsin deficiency, hemochromatosis, wilson's disease, primary sclerosing cholangitis, primary biliary cholangitis, or liver cirrhosis (child-pugh a, b, c) of any etiology. * use of medications or medical procedures that induce liver steatosis or fibrosis. * proven alcohol use exceeding: men \> 30 g/day, women \> 20 g/day. * history of acute or chronic pancreatitis. * known dependence on or use of illegal addictive substances. * significant weight gain or loss: +/- 10% in the last three months. * diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years. * stroke or myocardial infarction in the last 6 months. * clinically significant dyspnea new york hear association (nyha) grade iii or higher. * proven heart failure with a left ventricular ejection fraction below 40%. * estimated glomerular filtration rate(egfr) values lower than 30 ml/min/1.73 m² or creatinine clearance lower than 30 ml/min. * proven diabetic foot syndrome requiring amputation or with an existing defect. * planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential. * participation in another interventional study within the last 3 months before study entry. * legal incapacity or reduced ability to perform legal acts. * serving a prison sentence.