Clinical Trial

Reducing Non-Alcoholic Steatohepatitis

Study acronym: RedNASH
Enrolling by Invitation
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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).
Trial Details
NCT Number NCT06519448
Lead Sponsor Military University Hospital, Prague
Conditions Non-alcoholic Steatohepatitis, Liver Diseases, Diabetes Mellitus, Type 2, Fibrosis, Liver
Enrollment 30 participants
Start Date 2024-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-25