Reducing Non-Alcoholic Steatohepatitis

Korábbi kezelés

• Inability to safely discontinue thiazolidinedione (pioglitazone) therapy.
• Use of medications or medical procedures that induce liver steatosis or fibrosis.
• Participation in another interventional study within the last 3 months before study entry.

Más betegség

• 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.
• 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.
• History of acute or chronic pancreatitis.
• Diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years.
• Stroke or myocardial infarction in the last 6 months.
• Proven diabetic foot syndrome requiring amputation or with an existing defect.

Laborértékek

• HbA1c value > 80 mmol/mol.
• 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.

Egyéb

• Contraindication to liver biopsy.
• Documented episode of ketoacidosis.
• Proven alcohol use exceeding: Men > 30 g/day, Women > 20 g/day.
• Known dependence on or use of illegal addictive substances.
• Significant weight gain or loss: +/- 10% in the last three months.
• Clinically significant dyspnea New York hear association (NYHA) grade III or higher.
• Planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential.
• Legal incapacity or reduced ability to perform legal acts.
• Serving a prison sentence.

• 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.