Status:
ENROLLING_BY_INVITATION
Reducing Non-Alcoholic Steatohepatitis
Lead Sponsor:
Military University Hospital, Prague
Conditions:
Non-alcoholic Steatohepatitis
Liver Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 gradi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06519448
Start Date
April 1 2024
End Date
December 31 2027
Last Update
July 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Military Hospital
Prague, Czechia, 16902