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SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

NCT03867487•Justin Ryder

Summary

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.

Detailed Description

The overall aim of this pilot study is to evaluate the feasibility and obtain a preliminary estimate of efficacy and safety of the SGLT2 inhibitor, empagliflozin, in adolescents with obesity (BMI-percentile ≥95th) who have MRI-confirmed NAFLD (hepatic fat fraction ≥ 5.5%) and have normal fasting glucose. Participants will take empagliflozin, once daily, in the morning, with or without food, in addition to receiving lifestyle/behavioral counseling throughout the study. The following data will be collected throughout the course of the study: Physical exam with tanner staging, safety and fasting labs, fasting blood draw (biomarkers), urine sample, stool sample, OGTT, CGM sensor placement and removal, MRI scan (MRS-Liver), BMI/anthropometrics, urine pregnancy test for female participants, iDXA scan (body fat and bone density), arterial stiffness and blood pressure.

Eligibility

Age

12 - 20 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For clinical referral to screening visit:
•1. Age: 12 to \<20 years old
•2. Diagnosis of Obesity: BMI-percentile \>95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg/m2
•3. 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 prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 moths of screening
•4. History of lifestyle modification to treat obesity or NAFLD
•To be obtained at screening visit:
•1. Confirmation of Obesity
•2. Tanner stage 2,3,4 or 5;
•3. 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
+2 more criteria

Exclusion Criteria

•1. ALT \> 250U/L at screening
•2. History of significant alcohol intake or current use
•3. Impaired fasting glucose (\>100 mg/dL)
•4. Diabetes (type 1 or 2)
•5. Current or recent (\<6 months prior to enrollment) use of weight loss medication(s)
•6. Vitamin E supplementation
•7. Previous bariatric surgery
•8. Use of metformin
•9. Prior use of empagliflozin
•10. Lower limb infection/ulceration within 3 months of screening
+26 more criteria

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

May 1, 2027

Primary Completion Date

January 1, 2028

Completion Date

February 1, 2028

Last Updated

January 20, 2026

Enrollment

ESTIMATED participants

Conditions

Non-Alcoholic Fatty Liver DiseaseNAFLDPediatric NAFLD

Interventions

Empagliflozin 10 MG

DRUG

Placebo Oral Tablet

DRUG

Contacts

Farah Salim, M.S.

CONTACT

773-550-0749 SHIELD@luriechildrens.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

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