NCT06519448

Reducing Non-Alcoholic Steatohepatitis

Reducing Non-Alcoholic Steatohepatitis Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Military University Hospital, Prague · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 miligrams (mg)	Use of empagliflozin 10 mg daily for 12 months.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-07-25
• Last updated: 2024-07-25

Locations

1 site across 1 country: Czechia