Non-Alcoholic Fatty Liver DiseasePhase 2SLIDENCT03867487
SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
A Phase 2 study testing Empagliflozin 10 MG in people with Non-Alcoholic Fatty Liver Disease and NAFLD, run by Justin Ryder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, NAFLD, Pediatric NAFLD
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2027to 1 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For clinical referral to screening visit:
- Age: 12 to <20 years old
- Diagnosis of Obesity: BMI-percentile >95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg/m2
- 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
- History of lifestyle modification to treat obesity or NAFLD
- To be obtained at screening visit:
Show all 13Show fewer
- Confirmation of Obesity
- Tanner stage 2,3,4 or 5;
- Normal fasting glucose tolerance (fasting blood glucose <100 mg/dL)
- If Screening ALT is used as inclusion criteria [if > 2x historic ALT value (historical value obtained clinically within 12 months of screening visit), repeated after 4 weeks [unable to randomize until completed]]. If the repeat ALT is more than 50% increased or decreased over the screening ALT, a third ALT should be obtained. If a third ALT is not within 50% of the previous value, then the subject is ineligible but may be screened at a later date. If ALT is not used:
- 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
Who cannot join
- 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
Show all 36Show fewer
- Previous bariatric surgery
- Use of metformin
- 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
- 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)
- Tobacco use
- 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)
- Platelets < 150,000 cells/mm3
- Total bilirubin ≥ 1.3 mg/dL
- INR ≥ 1.3
- Albumin <3.2 g/dL
- Gilbert's Syndrome
- Any known causes of liver disease (except NAFLD and NASH)
- Significant renal dysfunction (estimated glomerular filtration rate [eGFR] < 80 mL/min/1.73 m2),
- Diagnosed monogenic obesity
- History of cancer
- Untreated thyroid disorder
- History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)
- Current or recent (<6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60601
Farah Salim, M.S., 773-550-0749, SHIELD@luriechildrens.org
Justin Ryder, PhD
About this study
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, NAFLD, Pediatric NAFLD
- Being tested
- Empagliflozin 10 MG, Placebo Oral Tablet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Jardiance
Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
Placebo Oral TabletDrug
Also called Control group
Participants will take an identical appearing oral tablet with zero active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Study intervention | Experimental | Empagliflozin 10 mg will be taken daily Receives: Drug: Empagliflozin 10 MG |
| Control arm | Placebo comparator | Placebo oral tablet will be taken daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)
HFF is measured by MRI via 1H- magnetic resonance spectroscopy (MRS). HFF will be measured with single-voxel 1H-MRS on a 3.0 T Trio whole body MRI scanner, using the software package provided by the vendor. The MR elastography measurement will consist of a phase-contrast 2D GRE scan (TR/TE = 50/25 ms, matrix 256 x 90, GRAPPA R=3, slice thickness 7mm) with motion encoding in the z-direction, and acoustic excitation at 60 Hz. Four axial slices will be acquired, each with a single breath-hold. Manual ROIs covering the liver will be drawn on the stiffness maps (in kPa units) generated by the system software. Fibrosis staging will be determined following previously published guidelines.
Measured: Baseline to 26 weeks
Secondary outcomes (9)
Change in Body Measurements: Body mass index (BMI)
Height and weight will be measured using a calibrated, wall-mounted stadiometer and an electronic scale, respectively. Three consecutive height and weight measurements will be obtained and averaged. BMI will be calculated as the weight in kilograms divided by the height in meters, squared.
Measured: Baseline to 26 weeks
Change in Body Measurements: Body Fat %
Total percent body fat mass and lean muscle mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Body fat percentage is calculated by body fat mass divided by the sum of fat and lean masses.
Measured: Baseline to 26 weeks
Change in Body Measurements: Visceral Fat %
Total body fat mass and visceral fat mass will be determined by dual energy x-ray absorptiometry (iDXA, GE Healthcare). Visceral fat percentage of total body mass is calculated by visceral fat mass divided by the sum of total fat and lean masses. Visceral fat percentage of total fat mass is calculated by visceral fat mass divided by total fat mass.
Measured: Baseline to 26 weeks
Change in Biomarkers of NAFLD: Alanine transaminase (ALT)
Fasting (≥12 hours) blood will be collected for the measurement of ALT at Fairview Diagnostics Laboratories, Fairview-University Medical Center, Minneapolis, MN - a Center for Disease Control and Prevention certified laboratory.
Measured: Baseline to 26 weeks
Change in Biomarkers of NAFLD: Cytokeratin (CK)-18
Fasting plasma samples will be used to measure CK-18 via Luminex Multiplex platform (Millipore, St. Louis, MO).
Measured: Baseline to 26 weeks
Change in Blood Pressure
Blood pressure measurements will be obtained manually on the same arm using the same cuff size and equipment. Standardized procedures will be employed as described in previously published standards. Individual cuff size will be determined by measuring the arm circumference midway between the acromial process and the bony olecranon. Sitting blood pressure and heart rate will be measured after the participant has been resting quietly without legs crossed for 10 minutes. Measurements will be made three consecutive times (3-minute intervals). The final two of three independent measurements will be averaged.
Measured: Baseline to 26 weeks
Change in Arterial Stiffness
Carotid- and femoral artery augmentation index and carotid-femoral pulse wave velocity (PWV) will be measured by the SphygmoCor® MM3 system (AtCor Medical, Sydney, Australia). Augmentation index is a measure of the relative magnitude of the reflected (or retrograde) pulse wave early in the cardiac cycle. Higher values of augmentation index represent increased arterial stiffening. PWV will be calculated as distance divided by transit time. Since pulse wave transit time decreases in stiffer arterial segments, higher values of pulse wave velocity represent increased arterial stiffness.
Measured: Baseline to 26 weeks
Change in Glycemic Control
After fasting measures are completed, we will perform a 2-hour oral glucose tolerance test with fasting (-15 and 0-min) and serial postprandial (15-, 30-, 45-, 60-, 90-, and 120-minutes) plasma concentrations of glucose (glucose oxidase, YSI INC., Yellow Sprigs, OH) and insulin (ELISA, ALPCO Diagnostics, Windham, NH) measured after administration of a 75g glucose challenge. Samples will be batched and a stored for analysis at the completion of the study. Insulin sensitivity will be estimated by the whole-body insulin sensitivity index (WBISI) using plasma glucose and insulin concentrations.
Measured: Baseline to 26 weeks
Change in Proton Density Fat Fraction (PDFF) from MRI
A proton density fat fraction (PDFF) image will be acquired using LiverLab's "qdixon" imaging acquisition (3D gradient echo, TR=9ms, flip angle=4°, TE=1.15, 2.46, 3.69, 4.92, 6.15, 7.38 ms, 2x2x3.5mm resolution, one 17s breath-hold). The MRS measurement of HFF will be used as the primary metric. As a secondary endpoint we will use PDFF which has shown promise as a measure of fibrosis staging compared to liver biopsy in children.
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 May 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Justin Ryder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Justin Ryder, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Justin Ryder, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867487
- Sponsor's protocol ID
- IRB 2023-6034
- Acronym
- SLIDE
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03867487
- Acronym / sponsor ID
- SLIDE / IRB 2023-6034
- Conditions
- Non-Alcoholic Fatty Liver Disease, NAFLD, Pediatric NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Justin RyderUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study intervention | Experimental | Drug: Empagliflozin 10 MGEmpagliflozin 10 mg will be taken daily |
| Control arm | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablet will be taken daily |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age: 12 to <20 years old
- Diagnosis of Obesity: BMI-percentile >95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg/m2
- 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
- History of lifestyle modification to treat obesity or NAFLD
- Confirmation of Obesity
Key exclusion criteria (36 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: JardianceParticipants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2) | Drug | Study intervention |
| Placebo Oral TabletAlso: Control groupParticipants will take an identical appearing oral tablet with zero active ingredient. | Drug | Control arm |
Primary outcome
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)
Time frame: Baseline to 26 weeks
HFF is measured by MRI via 1H- magnetic resonance spectroscopy (MRS). HFF will be measured with single-voxel 1H-MRS on a 3.0 T Trio whole body MRI scanner, using the software package provided by the vendor. The MR elastography measurement will consist of a phase-contrast 2D GRE scan (TR/TE = 50/25 ms, matrix 256 x 90, GRAPPA R=3, slice thickness 7mm) with motion encoding in the z-direction, and acoustic excitation at 60 Hz. Four axial slices will be acquired, each with a single breath-hold. Manual ROIs covering the liver will be drawn on the stiffness maps (in kPa units) generated by the system software. Fibrosis staging will be determined following previously published guidelines.
9 secondary outcomes
Change in Body Measurements: Body mass index (BMI)
Time frame: Baseline to 26 weeks
Change in Body Measurements: Body Fat %
Time frame: Baseline to 26 weeks
Change in Body Measurements: Visceral Fat %
Time frame: Baseline to 26 weeks
Change in Biomarkers of NAFLD: Alanine transaminase (ALT)
Time frame: Baseline to 26 weeks
Change in Biomarkers of NAFLD: Cytokeratin (CK)-18
Time frame: Baseline to 26 weeks
Change in Blood Pressure
Time frame: Baseline to 26 weeks
Change in Arterial Stiffness
Time frame: Baseline to 26 weeks
Change in Glycemic Control
Time frame: Baseline to 26 weeks
Change in Proton Density Fat Fraction (PDFF) from MRI
Time frame: Baseline to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Ryder, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG in people with Non-Alcoholic Fatty Liver Disease and NAFLD, run by Justin Ryder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farah Salim, M.S. (773-550-0749, SHIELD@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF) (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.