--- title: SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease nct_id: NCT03867487 overall_status: NOT_YET_RECRUITING phase: PHASE2 sponsor: Justin Ryder study_type: INTERVENTIONAL primary_condition: Non-Alcoholic Fatty Liver Disease countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03867487.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03867487" ct_last_update_post_date: 2026-01-20 last_seen_at: "2026-05-12T07:26:12.084Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease **NCT ID:** [NCT03867487](https://clinicaltrials.gov/study/NCT03867487) ## Key Facts - **Status:** NOT_YET_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 40 - **Lead Sponsor:** Justin Ryder - **Conditions:** Non-Alcoholic Fatty Liver Disease, NAFLD, Pediatric NAFLD - **Start Date:** 2027-05-01 - **Completion Date:** 2028-02-01 - **CT.gov Last Update:** 2026-01-20 ## Brief 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. ## Detailed 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 fasting labs, fasting blood draw (biomarkers), urine sample, stool sample, OGTT, CGM sensor placement and removal, MRI scan (MRS-Liver), BMI/anthropometrics, urine pregnancy test for female participants, iDXA scan (body fat and bone density), arterial stiffness and blood pressure. ## Eligibility - **Minimum age:** 12 Years - **Maximum age:** 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 To be obtained at screening visit: 1. Confirmation of Obesity 2. Tanner stage 2,3,4 or 5; 3. Normal fasting glucose tolerance (fasting blood glucose \<100 mg/dL) 4. If Screening ALT is used as inclusion criteria \[if \> 2x historic ALT value (historical value obtained clinically within 12 months of screening visit), repeated after 4 weeks \[unable to randomize until completed\]\]. If the repeat ALT is more than 50% increased or decreased over the screening ALT, a third ALT should be obtained. If a third ALT is not within 50% of the previous value, then the subject is ineligible but may be screened at a later date. If ALT is not used: * An ultrasound will be done to diagnose NAFLD if the diagnosis has not previously been made by ultrasound, MRI or biopsy * A MRI-derived HFF ≥ 5.5% 5. Willingness to adhere to lifestyle considerations throughout the study Exclusion Criteria: 1. ALT \> 250U/L at screening 2. History of significant alcohol intake or current use 3. Impaired fasting glucose (\>100 mg/dL) 4. Diabetes (type 1 or 2) 5. Current or recent (\<6 months prior to enrollment) use of weight loss medication(s) 6. Vitamin E supplementation 7. Previous bariatric surgery 8. Use of metformin 9. Prior use of empagliflozin 10. Lower limb infection/ulceration within 3 months of screening 11. Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible 12. Structural and functional urogenital abnormalities, that predispose for urogenital infections 13. Recent initiation (\<3 months prior to enrollment) of anti-hypertensive or lipid medication(s) 14. Major psychiatric disorder 15. Known hypothalamic or pituitary dysfunction 16. Current pregnancy or plans to become pregnant * Females unwilling to be tested for pregnancy * Females who are sexually active and not protected by an effective method of birth control (e.g. IUD or medication or patch) 17. Tobacco use 18. Significant liver dysfunction (levels \>5 times the upper limit of normal (ULN)): * ALT (ULN = 50 U/L) * AST (ULN = 48 U/L) * GGT (ULN = 48 U/L) * ALP (ULN = 115 U/L) 19. Platelets \< 150,000 cells/mm3 20. Total bilirubin ≥ 1.3 mg/dL 21. INR ≥ 1.3 22. Albumin \<3.2 g/dL 23. Gilbert's Syndrome 24. Any known causes of liver disease (except NAFLD and NASH) 25. Significant renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 80 mL/min/1.73 m2), 26. Diagnosed monogenic obesity 27. History of cancer 28. Untreated thyroid disorder 29. History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) 30. Current or recent (\<6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics). ``` ## Arms - **Study intervention** (EXPERIMENTAL) — Empagliflozin 10 mg will be taken daily - **Control arm** (PLACEBO_COMPARATOR) — Placebo oral tablet will be taken daily ## Interventions - **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. ## Primary Outcomes - **Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)** _(time frame: Baseline to 26 weeks)_ — 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. ## Secondary Outcomes - **Change in Body Measurements: Body mass index (BMI)** _(time frame: Baseline to 26 weeks)_ - **Change in Body Measurements: Body Fat %** _(time frame: Baseline to 26 weeks)_ - **Change in Body Measurements: Visceral Fat %** _(time frame: Baseline to 26 weeks)_ - **Change in Biomarkers of NAFLD: Alanine transaminase (ALT)** _(time frame: Baseline to 26 weeks)_ - **Change in Biomarkers of NAFLD: Cytokeratin (CK)-18** _(time frame: Baseline to 26 weeks)_ - **Change in Blood Pressure** _(time frame: Baseline to 26 weeks)_ - **Change in Arterial Stiffness** _(time frame: Baseline to 26 weeks)_ - **Change in Glycemic Control** _(time frame: Baseline to 26 weeks)_ - **Change in Proton Density Fat Fraction (PDFF) from MRI** _(time frame: Baseline to 26 weeks)_ ## Locations (1) - Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States ## Recent Field Changes (last 30 days) - `armsInterventions.arms` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.ann & robert h lurie children's hospital of chicago|chicago|illinois|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03867487.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03867487* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*