empagliflozin for Metabolic dysfunction-associated steatohepatitis|Non-alcoholic steatohepatitis (NASH)

Inclusion criteria

• {"criterion_text":"- • The ability and eligibility to sign informed consent."}
• {"criterion_text":"- • The age between 18 and 75 years of age at the beginning of the study."}
• {"criterion_text":"- • Verified/excluded diagnosis of DM2T according to the cohort. (OGTT HbA1c). Verified diagnosis of NASH determined by histology no older than 6 months before the administration of medication. The activity of the process must be determined by NAFLD Activity Score – NAS."}
• {"criterion_text":"- • Value of HbA1c ≤ 80 mmol/mol."}
• {"criterion_text":"- • In women of child bearing age a willingness to use at least 2 contraceptive methods"}

Exclusion criteria

• {"criterion_text":"- • Contraindication of liver biopsy"}
• {"criterion_text":"- • A documented episode of ketoacidosis"}
• {"criterion_text":"- • Contraindication or hypersensitivity to empagliflozin"}
• {"criterion_text":"- • A presence of an acute or chronic disease that could endanger the safety or health of the patient by discretion of the examiner"}
• {"criterion_text":"- • Value of HbA1c > 80 mmol/mol."}
• {"criterion_text":"- • The inability to exclude thiazolidinedione (pioglitazone) from chronic medication."}
• {"criterion_text":"- • Liver affection of different etiology, including hepatitis B a C , autoimmune hepatitis, alpha-1 antitrypsin insufficiency, hemochromatosis, Wilson disease, primary sclerosing cholangitis, primary biliary cirrhosis or liver cirrhosis (Child-Pugh A, B, C) of any etiology"}
• {"criterion_text":"- • The use of drugs or medicine inducing steatosis or liver fibrosis."}
• {"criterion_text":"- • Verified use of ethanol: men >30 g/day, woman > 20 g/day"}
• {"criterion_text":"- • History of acute o chronic pancreatitis."}
• {"criterion_text":"- • Known abuse of and or an addiction to illegal substances"}
• {"criterion_text":"- • A verified fluctuation of body weight +/- 10 % in the last 3 months."}
• {"criterion_text":"- • A diagnosis of a malignant disease (with the exclusion of threated dermal malignancies) in the last 5 years."}
• {"criterion_text":"- • Cerebral stroke or cardiac infarction in the last 6 months."}
• {"criterion_text":"- • Clinically significant shortness of breath defined as NYHA III or more."}
• {"criterion_text":"- • Verified heart failure with associated decrease of ejection fraction of the left ventricle less than 40 %."}
• {"criterion_text":"- • Values of eGFR lower than 30 ml/min/1,73 m2 or if CrCl is lower than 30 ml/min."}
• {"criterion_text":"- • Syndrome of the diabetic foot with the need for amputation or an active ulcer"}
• {"criterion_text":"- • Planed pregnancy, active lactation or pregnancy, positivity in a pregnancy test, absence of at least 2 adequate contraceptive methods in women of fertile age."}
• {"criterion_text":"- • Participation in a different study in the last 3 months before the start of the study."}
• {"criterion_text":"- • Incapacity or diminished capacity to perform legal acts."}
• {"criterion_text":"- • Pending execution of a sentence."}

Primary endpoints

• {"endpoint_text":"- Decrease of a histological score of NASH","definition_or_measurement_approach":"Assessed by liver histology; histological grade/NASH stage evaluation (NAFLD Activity Score – NAS is referenced in eligibility and objective)."}

Secondary endpoints

• {"endpoint_text":"- Decrease of fibrosis stage assessed by non-invasive liver elastography. Improvement of laboratory results and anthropometric data","definition_or_measurement_approach":"Fibrosis stage assessed by non-invasive liver elastography; laboratory results and anthropometric data measured by standard clinical laboratory tests and anthropometric measurements (as stated)."}

Czechia

Earliest CTIS Part Ii Submission Date

22-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia