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Empagliflozin for Pediatric Non-Alcoholic Fatty Liver Disease

This study is looking into empagliflozin, a medication taken by mouth, as a possible treatment for Non-Alcoholic Fatty Liver Disease (NAFLD) in adolescents. NAFLD is a condition where too much fat builds up in the liver. You might be able to join if you are between 12 and 20 years old, have obesity, and have elevated liver enzymes (ALT levels). Participants will either receive empagliflozin or a placebo (an inactive pill that looks the same) along with lifestyle counseling. The main goal is to see if empagliflozin can reduce the amount of fat in the liver over 26 weeks. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the study drug or a placebo, and neither you nor your doctors will know which you are receiving. It aims to enroll 40 participants.
What's involved
You would take empagliflozin or a placebo once daily and receive lifestyle counseling. You would also have physical exams, blood and urine tests, an MRI scan of your liver, and other measurements like body fat scans.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in liver fat up to 26 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03867487

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

Not Yet Recruiting
PHASE2Ages 12–20InterventionalTreatment
Justin Ryder
~40 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Empagliflozin 10 MGPlacebo Oral Tablet

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)
Measured over Baseline to 26 weeks

Conditions

Non-Alcoholic Fatty Liver Disease
NAFLD
Pediatric NAFLD

Explore related trials

Nonalcoholic Fatty Liver Disease

NCT03867487

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinoisstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Justin Ryder, PhD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

Who to contact

Farah Salim, M.S.
[email protected]
773-550-0749
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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).

What this trial measures

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