Clinical Research Directory

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.