Authorised Therapeutic use (Phase IV) Metabolic dysfunction-associated steatohepatitis

Reducing Non-Alcoholic Steatohepatitis

EU CTIS ID: 2024-518334-88-00

What this study is testing

Evaluation of histological grade and NASH stage in patients with verified NASH during 48-week long empagliflozin therapy.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • The ability and eligibility to sign informed consent. • The age between 18 and 75 years of age at the beginning of the study. • 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. • Value of HbA1c ≤ 80 mmol/mol. • In women of child bearing age a willingness to use at least 2 contraceptive methods

You likely can't join if

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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.