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New treatment option for Non-Alcoholic Fatty Liver Disease
Official title Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease
ClinicalTrials.gov ID: NCT06355310
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-alcoholic fatty liver disease.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 20
You may be able to join 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...
You likely can't join 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
See the full eligibility 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...
- 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 (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...
- 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.