Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

NCT06355310 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB 2023-6429
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hepatic Fat

  change in hepatic fat fraction (Hepatic fat will be measured by MRI via proton density fat fraction (PDFF)) from baseline (first measurement time point) to 26-weeks.

  26-Weeks

Secondary Outcomes (1)

• Body mass index

  26-Weeks

Study Arms (2)

Study intervention

EXPERIMENTAL

Empagliflozin 10 mg will be taken daily

Drug: Empagliflozin 10 MG

Control arm

PLACEBO COMPARATOR

Placebo oral tablet will be taken daily

Drug: Placebo Oral Tablet

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)

Also known as: Jardiance

Study intervention

Placebo Oral Tablet DRUG

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

Also known as: Control group

Control arm

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)
• To be obtained at screening visit:
• Confirmation of obesity;
• Tanner stage 2,3,4 or 5;
• 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.
• A MRI-derived HFF ≥ 5.5%
• Willingness to adhere to lifestyle considerations throughout the study

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
• Prior use of empagliflozin
• Lower limb infection/ulceration within 3 months of screening
• Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible
• Structural and functional urogenital abnormalities, that predispose for urogenital infections
• Recent initiation (\<3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
• Major psychiatric disorder
• Known hypothalamic or pituitary dysfunction

Sponsors & Collaborators

• Justin Ryder: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

empagliflozin; Control Groups

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Justin Ryder, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farah Salim, M.S.

CONTACT

773-550-0749; SHIELD@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Research for the Department of Surgery at Ann & Robert H Lurie Children's Hospital

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 9, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)