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RecruitingNon-Alcoholic Fatty Liver Disease

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

Eligible age

16–20 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Justin Ryder

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)

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

Where it's recruiting

Illinois

Chicago

Source: ClinicalTrials.gov · NCT06355310 · last updated 2026-01-21

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease · TrialPath