Actively Recruiting
Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
Led by Justin Ryder · Updated on 2026-01-21
40
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and under 21 years at baseline
- Body mass index (BMI) greater than 30 kg/m2 or above the 95th BMI percentile
- Weight between 75 kg and 150 kg
- 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 before screening or diagnosis of NAFLD via ultrasound, MRI, or biopsy-proven NASH within 12 months
- History of lifestyle changes to treat obesity or NAFLD
- Tanner stage greater than 2
- Normal fasting glucose level (less than 100 mg/dL)
- Confirmation of obesity and Tanner stage 2 to 5 at screening
- Normal fasting glucose tolerance at screening
- MRI-derived hepatic fat fraction of 5.5% or higher if diagnosis not previously made
- Willingness to follow lifestyle recommendations during the study
You will not qualify if you...
- ALT level above 250 U/L at screening
- History or current use of significant alcohol
- Impaired fasting glucose over 100 mg/dL
- Type 1 or type 2 diabetes
- Use of weight loss medications within 6 months before enrollment
- Vitamin E supplementation or metformin use within 30 days prior
- Prior bariatric surgery
- Previous use of empagliflozin
- Lower limb infection or ulcer within 3 months before screening
- Presence of metal or magnetic implants incompatible with MRI
- Structural or functional urogenital abnormalities increasing infection risk
- Recent start of anti-hypertensive or lipid medications within 3 months
- Major psychiatric disorders
- Known hypothalamic or pituitary dysfunction
- Current pregnancy or plans to become pregnant
- Females unwilling to undergo pregnancy testing or not using effective birth control if sexually active
- Tobacco use
- Significant liver dysfunction (specific lab thresholds exceeded)
- Platelet count below 150,000 cells/mm3
- Total bilirubin over 1.3 mg/dL
- INR over 1.3
- Albumin below 3.2 g/dL
- Gilbert's Syndrome
- Other known causes of liver disease besides NAFLD/NASH
- Significant kidney dysfunction (eGFR below 80 mL/min/1.73 m2)
- Diagnosed monogenic obesity
- History of cancer
- Untreated thyroid disorder
- History of liver decompensation events
- Use of medications linked to weight gain within 6 months before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
F
Farah Salim, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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