Using SGLT2 inhibitors to treat fatty liver disease in obese adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the feasibility, initial efficacy, and safety of the SGLT2 inhibitor empagliflozin in adolescents with obesity and non-alcoholic fatty liver disease (NAFLD). Participants aged 16 to 21 with a BMI in the 95th percentile or higher will receive either empagliflozin or a placebo, alongside lifestyle and behavioral counseling. The study will collect various health data, including physical exams, lab tests, and MRI scans, to assess the treatment's impact on liver health and overall well-being.

Why it matters

Who can join: the full rules

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).

Where it's running

• Ann & Robert H Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Justin Ryder, PhD — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Farah Salim, M.S.
• Email: SHIELD@luriechildrens.org
• Phone: 773-550-0749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver

  We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07599241

• Lowering insulin to reduce liver fat production

  This study will try a short course of diazoxide to lower insulin and see if it reduces the liver's creation of new fat in adults with obesity, insulin resistance, and MASLD.

  Recruiting Phase 1 Columbia University · New York, New York · NCT07403604

• Efimosfermin alfa for adults with liver impairment

  This trial will test a single dose of efimosfermin alfa in adults with cirrhosis-related hepatic impairment from steatotic liver disease, with and without significant alcohol use, to measure drug levels and safety.

  Recruiting at 5 sites Phase 1 GlaxoSmithKline · Rialto, California and 4 other locations · NCT07358546

• Efimosfermin alfa for adults with biopsy-confirmed F2 or F3 MASH

  This trial will test whether efimosfermin alfa can resolve steatohepatitis and improve liver-related outcomes in adults with biopsy-confirmed F2 or F3 MASH.

  Recruiting at 91 sites Phase 3 GlaxoSmithKline · Chandler, Arizona and 90 other locations · NCT07221227

• Efimosfermin alfa injections for adults with F2–F3 MASH

  This study tests whether efimosfermin alfa injections are safe and tolerable for adults (18–75) with known or suspected metabolic dysfunction-associated steatohepatitis (MASH) and F2–F3 fibrosis.

  Recruiting at 66 sites Phase 3 GlaxoSmithKline · Arcadia, California and 65 other locations · NCT07221188

• Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver

  This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07130318

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.