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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Empagliflozin 10 MG
Drug
Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
Placebo Oral Tablet
Drug
Participants will take an identical appearing oral tablet with zero active ingredient.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Study interventionExperimental treatment 1 intervention

Group B: Control armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Hepatic Fat

change in hepatic fat fraction (Hepatic fat will be measured by MRI via proton density fat fraction (PDFF)) from baseline (first measurement time point) to 26-weeks.

Time frame

26-Weeks

Secondary outcomes

Body mass index

* BMI * body fat% (total and visceral fat) * ALT * biomarkers of NAFLD oCK-18 ototal and activated PAI-1 oIL-8 * biomarkers of bone health (additional safety outcome) oN-terminal collagen type I extension propeptide (PINP) oOsteocalcin oC-terminal cross-linking telopeptide of type I collagen (CTX) * Systolic and diastolic blood pressure * glycemic control (from oral glucose tolerance test) * Insulin sensitivity (from oral glucose tolerance test) by the whole-body insulin sensitivity index

Time frame

26-Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Justin Ryder

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution

Source ClinicalTrials.gov

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