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

NCT03867487 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • NAFLD
  • Pediatric NAFLD

Interventions

DRUG

Placebo Oral Tablet

Participants will take an identical appearing oral tablet with zero active ingredient.

DRUG

Empagliflozin 10 MG

Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)

Sponsors & Collaborators

  • Justin Ryder

    lead OTHER

Principal Investigators

  • Justin Ryder, PhD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-05-01
Primary Completion
2028-01-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867487 on ClinicalTrials.gov