Non-Alcoholic Fatty Liver Disease study: Empagliflozin
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?
An investigational oral tablet being studied as a potential treatment for non‑alcoholic fatty liver disease in adolescents with obesity. It is designed to inhibit the sodium‑glucose co‑transporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption.
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
- The study will see if the drug is safe, works a little, and can be used in children with fatty liver disease.
- Who it's for
- Teenagers with obesity and non‑alcoholic fatty liver disease
- What's involved
- Participants will receive either the drug or a placebo, and will have regular visits and tests to monitor safety and liver health.
- Time commitment
- The trial lasts several months with multiple clinic visits for medication and health checks.
- 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
- 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...
- History of lifestyle modification to treat obesity or NAFLD.
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
- 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
- Confirmation of obesity;
- Tanner stage 2,3,4 or 5;
- 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%
- 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
- 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 is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.