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Could a common diabetes drug shrink fatty livers in obese teens?

NCT ID NCT06355310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether empagliflozin (Jardiance), a drug used for diabetes, can reduce liver fat in teenagers with obesity and non-alcoholic fatty liver disease (NAFLD). Forty participants aged 16 to under 21 will receive either the drug or a placebo for 26 weeks. The main goal is to see if liver fat decreases, along with other health markers like weight and liver enzymes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin (Jardiance)
What this could lead to
If it works, this could point toward a new treatment option for teenagers with fatty liver disease, potentially reducing liver fat and improving metabolic health.
What could go wrong
This is an early Phase 2 trial with only 40 participants, so results may not apply to everyone. The drug is already approved for diabetes, but its safety and effectiveness for this specific condition in teens are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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); * 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 Exclusion Criteria: * 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 * 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

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