Reducing Non-Alcoholic Steatohepatitis

NCT ID: NCT06519448

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-12-31

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 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).

Conditions

Non-alcoholic Steatohepatitis; Liver Diseases; Diabetes Mellitus, Type 2; Fibrosis, Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NASH

Patients with histological proven NASH (either diabetics and non-diabetics).

Group Type: EXPERIMENTAL

Empagliflozin 10 miligrams (mg)

Intervention Type: DRUG

Use of empagliflozin 10 mg daily for 12 months.

Interventions

Empagliflozin 10 miligrams (mg)

Use of empagliflozin 10 mg daily for 12 months.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Petr Hribek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Central Military Hospital

Prague, , Czechia

Countries

Czechia

Other Identifiers

RedNASH

Identifier Type: -

Identifier Source: org_study_id