Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients. The primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• MAFLD patients (hepatic steatosis plus metabolic dysfunction

• ALT elevation (>35 U/L in male and >25 U/L in female) or FIB-4 >=1.45

Exclusion Criteria:

1. diabetes history or HbA1C> 6.5

2. cancer history

3. systolic blood pressure < 100 mmHg

4. eGFR < 30 ml/min/1.73m2

5. history of urinary tract infection/genital yeast infection