[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543395":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":62,"collaborators":43,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":43,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":43,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study intervention","EXPERIMENTAL","Empagliflozin 10 mg will be taken daily",[13],"Drug: Empagliflozin 10 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","PLACEBO_COMPARATOR","Placebo oral tablet will be taken daily",[19],"Drug: Placebo Oral Tablet",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Empagliflozin 10 MG","Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)",[9],[27],"Jardiance",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo Oral Tablet","Participants will take an identical appearing oral tablet with zero active ingredient.",[15],[33],"Control group",[35],{"name":36,"affiliation":5,"role":37},"Justin Ryder, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Farah Salim, M.S.","CONTACT","773-550-0749",null,"SHIELD@luriechildrens.org",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-87.65005,41.85003,{"lat":57,"lon":56},[60,61],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":36,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Justin Ryder","Vice Chair of Research for the Department of Surgery at Ann & Robert H Lurie Children's Hospital","100543395","phase-2-mechanisms-of-sglt2-inhibition-in-pediatric-steatotic-liver-disease-100543395",false,"NCT06355310","Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease","SHIELD","Inclusion Criteria:\n\nFor clinical referral to screening visit:\n\n* BMI \\>30 kg\u002Fm2 or \\>95th BMI-Percentile\n* Weight Range of 75kg to 150kg\n* Age 16 to \\\u003C21 at baseline\n* Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥ 44 U\u002FL for girls, ≥ 50 U\u002FL 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.\n* History of lifestyle modification to treat obesity or NAFLD.\n* Tanner stage \\>2\n* Normal fasting glucose (fasting blood glucose \\\u003C100 mg\u002FdL)\n\nTo be obtained at screening visit:\n\n* Confirmation of obesity;\n* Tanner stage 2,3,4 or 5;\n* Normal fasting glucose tolerance (fasting blood glucose \\\u003C100 mg\u002FdL);\n* 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:\n\n  * An ultrasound will be done to diagnose NAFLD if the diagnosis has not previously been made by ultrasound, MRI or biopsy.\n  * A MRI-derived HFF ≥ 5.5%\n* Willingness to adhere to lifestyle considerations throughout the study\n\nExclusion Criteria:\n\n* ALT \\> 250U\u002FL at screening\n* History of significant alcohol intake or current use\n* Impaired fasting glucose (\\>100 mg\u002FdL)\n* Diabetes (type 1 or 2)\n* Current or recent (\\\u003C6 months prior to enrollment) use of weight loss medication(s)\n* Vitamin E supplementation or use of metformin\n\n  -washout period 30 days\n* Previous bariatric surgery\n* Prior use of empagliflozin\n* Lower limb infection\u002Fulceration within 3 months of screening\n* Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible\n* Structural and functional urogenital abnormalities, that predispose for urogenital infections\n* Recent initiation (\\\u003C3 months prior to enrollment) of anti-hypertensive or lipid medication(s)\n* Major psychiatric disorder\n* Known hypothalamic or pituitary dysfunction\n* Current pregnancy or plans to become pregnant\n* Females unwilling to be tested for pregnancy\n* Females who are sexually active and not protects by an effective method of birth control (e.g. UID or medication or patch)\n\n  -can re-screen 30 days after getting on birth control\n* Tobacco use\n* Significant liver dysfunction (levels \\>5 times the upper limit of normal (ULN)):\n* ALT (ULN = 50 U\u002FL)\n* AST (ULN = 48 U\u002FL)\n* GGT (ULN = 48 U\u002FL)\n* ALP (ULN = 115 U\u002FL)\n* Platelets \\\u003C 150,000 cells\u002Fmm3\n* Total bilirubin \\> 1.3 mg\u002FdL\n* INR \\> 1.3\n* Albumin \\\u003C3.2 g\u002FdL\n* Gilbert's Syndrome\n* Any known causes of liver disease (except NAFLD and NASH)\n* Significant renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 80 mL\u002Fmin\u002F1.73 m2),\n* Diagnosed monogenic obesity\n* History of cancer\n* Untreated thyroid disorder\n* History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)\n* Current or recent (\\\u003C6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).","ALL","16 Years","20 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","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.",[84],"Non-Alcoholic Fatty Liver Disease","2026-01-20",{"date":87,"type":88},"2026-01-21","ACTUAL",{"date":90,"type":88},"2025-04-10",{"date":92,"type":78},"2028-02-01",{"name":64,"class":6},1]