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SLIDE: Empagliflozin in Pediatric NAFLD
NCT03867487Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- May 2027
- Primary completion
- Jan 2028
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- empagliflozin
- Conditions
- non-alcoholic fatty liver disease (NAFLD)
01
Overview
Phase 2, randomised, double-blind trial of empagliflozin in non-alcoholic fatty liver disease (NAFLD) (2 arms). Primary endpoint: Hepatic Fat Fraction at 26 weeks. Planned start May 2027; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Study intervention
Empagliflozin 10 mg daily
Control arm
Placebo daily
03
Who it enrols
Adolescents aged 12 to <20 years with obesity and MRI-confirmed NAFLD or elevated ALT, with normal fasting glucose, excluding those with diabetes, significant liver/renal dysfunction, or recent use of weight loss/lipid/anti-hypertensive medications.
04
Endpoints
Primary
Hepatic Fat Fraction
Secondary
Body Mass Index
Body Fat Percentage
Visceral Fat Percentage
Alanine Transaminase
Cytokeratin-18
Blood Pressure
Arterial Stiffness
Glycemic Control
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