Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Justin Ryder
- Study ID
- NCT06355310
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - 20 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin 10 MG — DRUGParticipants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
- Placebo Oral Tablet — DRUGParticipants will take an identical appearing oral tablet with zero active ingredient.
Study Details
This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.
Key Dates
- Start date
- Apr 10, 2025
- Status verified
- Jan 2026
- Primary completion
- Jan 1, 2028
- Completion
- Feb 1, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Study interventionEmpagliflozin 10 mg will be taken daily
- Placebo Comparator: Control armPlacebo oral tablet will be taken daily
Primary Outcome Measure
Hepatic Fat [ Time Frame: 26-Weeks ]
Central Contacts
- Farah Salim, M.S.773-550-0749
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Justin Ryder, PhD (PRINCIPAL_INVESTIGATOR) |
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