AzTrials
AzTrials

Non-Alcoholic Fatty Liver DiseasePhase 2SHIELDNCT06355310

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

A Phase 2 study testing Empagliflozin 10 MG in people with Non-Alcoholic Fatty Liver Disease, run by Justin Ryder at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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 16 to 20 years
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
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
10 Apr 2025to 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 16 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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);
  • 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 rescreened 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 or use of metformin
Show all 37Show fewer
  • -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
  • Current pregnancy or plans to become pregnant
  • Females unwilling to be tested for pregnancy
  • Females who are sexually active and not protects by an effective method of birth control (e.g. UID or medication or patch)
  • -can re-screen 30 days after getting on birth control
  • 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.

Farah Salim, M.S. contact

773-550-0749

SHIELD@luriechildrens.org

United States1 site, 1 recruiting

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Farah Salim, M.S., 773-550-0749, SHIELD@luriechildrens.org

    Justin Ryder, PhD

    Recruiting

Other trials in United States

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, 2-stage clamp (overnight Stay),Stable isotope tracers (overnight Stay), MRI scan (MRS-Liver), BMI/anthropometrics, urine pregnancy test for female participants, iDXA scan (body fat and bone density), arterial stiffness and blood pressure.

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 groups in NCT06355310
Study groupRoleWhat they receive
Study interventionExperimentalEmpagliflozin 10 mg will be taken daily
Receives: Drug: Empagliflozin 10 MG
Control armPlacebo comparatorPlacebo 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.

  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.

    Measured: 26-Weeks

Secondary outcomes (1)

  1. Body mass index

    • BMI
    • body fat% (total and visceral fat)
    • ALT
    • biomarkers of NAFLD oCK-18 ototal and activated PAI-1 oIL-8
    • biomarkers of bone health (additional safety outcome) oN-terminal collagen type I extension propeptide (PINP) oOsteocalcin oC-terminal cross-linking telopeptide of type I collagen (CTX)
    • Systolic and diastolic blood pressure
    • glycemic control (from oral glucose tolerance test)
    • Insulin sensitivity (from oral glucose tolerance test) by the whole-body insulin sensitivity index

    Measured: 26-Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start10 Apr 2025
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

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
Model description
1:1 randomization
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355310
Sponsor's protocol ID
IRB 2023-6429
Acronym
SHIELD
Status last verified
Jan 2026
First submitted
1 Apr 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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, 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 16 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 21 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?

Hepatic Fat (time frame: 26-Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06355310.

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 21 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in