Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID: NCT06355310
Run by: Justin Ryder
People needed: 40
Starts: 2025-04-10
Expected to finish: 2028-02-01
Last updated by the study team: 2026-01-21

Who can join

Age: 16 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For clinical referral to screening visit:
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)
To be obtained at screening visit:
Confirmation of obesity;
Tanner stage 2,3,4 or 5;
Normal fasting glucose tolerance (fasting blood glucose <100 mg/dL);
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 rescreened 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%
Willingness to adhere to lifestyle considerations throughout the study

You may not qualify if…

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)

Where it is running

Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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