Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

ConditionNon-Alcoholic Fatty Liver Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age16-20

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

BMI >30 kg/m2 or >95th BMI-Percentile

Weight Range of 75kg to 150kg

Age 16 to <21 at baseline

Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥ 44 U/L for girls, ≥ 50 U/L for boys)63 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 months of screening.

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 groups

Sponsors and collaborators

Justin Ryder

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution

Source ClinicalTrials.gov