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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-05-01

Study Completion Date

2028-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease NAFLD Pediatric NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double blind clinical trial in which the study team and the participants are blinded to whether the subject received placebo or study drug.

Study Groups

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Study intervention

Empagliflozin 10 mg will be taken daily

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

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

Control arm

Placebo oral tablet will be taken daily

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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Empagliflozin 10 MG

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

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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Jardiance Control group

Eligibility Criteria

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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
* A MRI-derived HFF ≥ 5.5%
5. Willingness to adhere to lifestyle considerations throughout the study

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
11. Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible
12. Structural and functional urogenital abnormalities, that predispose for urogenital infections
13. Recent initiation (\<3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
14. Major psychiatric disorder
15. Known hypothalamic or pituitary dysfunction
16. Current pregnancy or plans to become pregnant

* Females unwilling to be tested for pregnancy
* Females who are sexually active and not protected by an effective method of birth control (e.g. IUD or medication or patch)
17. Tobacco use
18. Significant liver dysfunction (levels \>5 times the upper limit of normal (ULN)):

* ALT (ULN = 50 U/L)
* AST (ULN = 48 U/L)
* GGT (ULN = 48 U/L)
* ALP (ULN = 115 U/L)
19. Platelets \< 150,000 cells/mm3
20. Total bilirubin ≥ 1.3 mg/dL
21. INR ≥ 1.3
22. Albumin \<3.2 g/dL
23. Gilbert's Syndrome
24. Any known causes of liver disease (except NAFLD and NASH)
25. Significant renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 80 mL/min/1.73 m2),
26. Diagnosed monogenic obesity
27. History of cancer
28. Untreated thyroid disorder
29. History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)
30. Current or recent (\<6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).

Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No