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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Justin Ryder
Study ID
NCT03867487
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
  • Placebo Oral Tablet — DRUG
    Participants will take an identical appearing oral tablet with zero active ingredient.

Study Details

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 Dates

Start date
May 1, 2027
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study intervention
    Empagliflozin 10 mg will be taken daily
  • Placebo Comparator: Control arm
    Placebo oral tablet will be taken daily

Primary Outcome Measure

Efficacy as Measured by Change in Hepatic Fat Fraction (HFF) [ Time Frame: Baseline to 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60601
Farah Salim, M.S.
[email protected]
773-550-0749
Justin Ryder, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Ann & Robert H Lurie Children's Hospital of Chicago· Chicago, IL

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