SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
Justin Ryder
Summary
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.
Description
The overall aim of this pilot study is to evaluate the feasibility and obtain a preliminary estimate of efficacy and safety of the SGLT2 inhibitor, empagliflozin, in adolescents with obesity (BMI-percentile ≥95th) who have MRI-confirmed NAFLD (hepatic fat fraction ≥ 5.5%) and have normal fasting glucose. Participants will take empagliflozin, once daily, in the morning, with or without food, in addition to receiving lifestyle/behavioral counseling throughout the study. The following data will be collected throughout the course of the study: Physical exam with tanner staging, safety and fastin…
Eligibility
- Age range
- 12–20 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For clinical referral to screening visit: 1. Age: 12 to \<20 years old 2. Diagnosis of Obesity: BMI-percentile \>95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg/m2 3. Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥44 U/L for girls, ≥50 U/L for boys) within 3 months prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 moths of screening 4. History of lifestyle modification to treat obesity or NAFLD T…
Interventions
- DrugEmpagliflozin 10 MG
Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
- DrugPlacebo Oral Tablet
Participants will take an identical appearing oral tablet with zero active ingredient.
Location
- Ann & Robert H Lurie Children's Hospital of ChicagoChicago, Illinois