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Empagliflozin for Pediatric Steatotic Liver Disease

This study is looking into how well and how safely a medication called empagliflozin works for adolescents (ages 16 to 20) who have non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where too much fat builds up in the liver. Participants will either take a 10 mg empagliflozin tablet or a placebo (an inactive pill that looks the same) once daily. The main goal is to see if empagliflozin can reduce the amount of fat in the liver after 26 weeks. To join, you need to be between 16 and 20 years old, have a high BMI (Body Mass Index), and elevated liver enzymes (ALT). The study status is currently unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with 40 participants. This means participants are randomly assigned to receive either empagliflozin or a placebo, and neither you nor the study team will know which you are receiving.
What's involved
Participants will take a daily pill and receive lifestyle counseling. You will have physical exams, blood draws, urine samples, an overnight stay for special tests, MRI scans, and body fat measurements.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring liver fat is at 26 weeks, which suggests follow-up will occur at least until this time.

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

NCT06355310

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

Recruiting
PHASE2Ages 16–20InterventionalTreatment
Justin Ryder
~40 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Empagliflozin 10 MGPlacebo Oral Tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatic Fat
Measured over 26-Weeks

Conditions

Non-Alcoholic Fatty Liver Disease

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Nonalcoholic Fatty Liver Disease

NCT06355310

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

    Recruiting

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

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.
History of lifestyle modification to treat obesity or NAFLD.
Tanner stage \>2
Normal fasting glucose (fasting blood glucose \<100 mg/dL)
Confirmation of obesity;
Tanner stage 2,3,4 or 5;
Normal fasting glucose tolerance (fasting blood glucose \<100 mg/dL);
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%
Willingness to adhere to lifestyle considerations throughout the study

Exclusion

ALT \> 250U/L at screening
History of significant alcohol intake or current use
Impaired fasting glucose (\>100 mg/dL)
Diabetes (type 1 or 2)
Current or recent (\<6 months prior to enrollment) use of weight loss medication(s)
Vitamin E supplementation or use of metformin
washout period 30 days
Previous bariatric surgery
Prior use of empagliflozin
Lower limb infection/ulceration within 3 months of screening
Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible
Structural and functional urogenital abnormalities, that predispose for urogenital infections
Recent initiation (\<3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
Major psychiatric disorder
Known hypothalamic or pituitary dysfunction
Current pregnancy or plans to become pregnant
Females unwilling to be tested for pregnancy
Females who are sexually active and not protects by an effective method of birth control (e.g. UID or medication or patch)
can re-screen 30 days after getting on birth control
Tobacco use
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)
Platelets \< 150,000 cells/mm3
Total bilirubin \> 1.3 mg/dL
INR \> 1.3
Albumin \<3.2 g/dL
Gilbert's Syndrome
Any known causes of liver disease (except NAFLD and NASH)
Significant renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 80 mL/min/1.73 m2),
Diagnosed monogenic obesity
History of cancer
Untreated thyroid disorder
History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)
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

  • Hepatic Fat26-Weeks

    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.