Health TrialsbyHealthPanel

SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease

ConditionsNon-Alcoholic Fatty Liver DiseaseNAFLDPediatric NAFLD
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

This trial does not accept healthy volunteers

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

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

1

Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)

HFF is measured by MRI via 1H- magnetic resonance spectroscopy (MRS). HFF will be measured with single-voxel 1H-MRS on a 3.0 T Trio whole body MRI scanner, using the software package provided by the vendor. The MR elastography measurement will consist of a phase-contrast 2D GRE scan (TR/TE = 50/25 ms, matrix 256 x 90, GRAPPA R=3, slice thickness 7mm) with motion encoding in the z-direction, and acoustic excitation at 60 Hz. Four axial slices will be acquired, each with a single breath-hold. Manual ROIs covering the liver will be drawn on the stiffness maps (in kPa units) generated by the system software. Fibrosis staging will be determined following previously published guidelines.

Time frame
Baseline to 26 weeks

Secondary outcomes

1

Change in Body Measurements: Body mass index (BMI)

Height and weight will be measured using a calibrated, wall-mounted stadiometer and an electronic scale, respectively. Three consecutive height and weight measurements will be obtained and averaged. BMI will be calculated as the weight in kilograms divided by the height in meters, squared.

Time frame
Baseline to 26 weeks
2

Change in Body Measurements: Body Fat %

Total percent body fat mass and lean muscle mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Body fat percentage is calculated by body fat mass divided by the sum of fat and lean masses.

Time frame
Baseline to 26 weeks
3

Change in Body Measurements: Visceral Fat %

Total body fat mass and visceral fat mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Visceral fat percentage of total body mass is calculated by visceral fat mass divided by the sum of total fat and lean masses. Visceral fat percentage of total fat mass is calculated by visceral fat mass divided by total fat mass.

Time frame
Baseline to 26 weeks
4

Change in Biomarkers of NAFLD: Alanine transaminase (ALT)

Fasting (≥12 hours) blood will be collected for the measurement of ALT at Fairview Diagnostics Laboratories, Fairview-University Medical Center, Minneapolis, MN - a Center for Disease Control and Prevention certified laboratory.

Time frame
Baseline to 26 weeks

Other outcomes

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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