Reducing Non-Alcoholic Steatohepatitis (RedNASH)

Military University Hospital, Prague

Status

Invitation-only

Conditions

Fibrosis, Liver

Non-alcoholic Steatohepatitis

Diabetes Mellitus, Type 2

Liver Diseases

Treatments

Drug: Empagliflozin 10 miligrams (mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT06519448

RedNASH

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.