Tests empagliflozin for non-alcoholic steatohepatitis, a fatty liver disease
Tests empagliflozin, a diabetes pill, in adults with fatty liver inflammation.
Plain-language title generated from the registry record
Registry title: Reducing Non-Alcoholic Steatohepatitis
Key facts
- Where
- Prague 6, CzechiaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06519448, who can take part
Where in Czechia
- Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice PrahaPrague 6, CzechiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Military University Hospital, Prague
- Trial code
- NCT06519448EU 2024-518334-88-00
- Record updated
- 25 July 2024
- Original description
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are:Read full original descriptionShow less
Reducing Non-Alcoholic Steatohepatitis Study
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).
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: 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; 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; 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; 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.