SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-20
SponsorJustin Ryder
About this trial
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.
Eligibility criteria
Qualifiers
Age: 12 to <20 years old
Diagnosis of Obesity: BMI-percentile >95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg/m2
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
History of lifestyle modification to treat obesity or NAFLD
Disqualifiers
ALT > 250U/L at screening
History of significant alcohol intake or current use
Impaired fasting glucose (>100 mg/dL)
Diabetes (type 1 or 2)
Trial design
Treatments tested in this trial
- Empagliflozin 10 MG
- Placebo Oral Tablet
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Justin Ryder
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Source ClinicalTrials.gov