[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Justin Ryder\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Non-Alcoholic Fatty Liver Disease","RECRUITING","2026-01-20",{"date":31,"type":32},"2026-01-21","ACTUAL",{"date":34,"type":32},"2025-04-10",{"date":36,"type":21},"2028-02-01",{"name":38,"class":39},"Justin Ryder","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":25,"conditions":51,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":40},"100352332","phase-2-sglt2-inhibitors-as-a-novel-treatment-for-pediatric-non-alcoholic-fatty-liver-disease-100352332","NCT03867487","SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease","SLIDE","Inclusion Criteria:\n\nFor clinical referral to screening visit:\n\n1. Age: 12 to \\\u003C20 years old\n2. Diagnosis of Obesity: BMI-percentile \\>95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg\u002Fm2\n3. Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥44 U\u002FL for girls, ≥50 U\u002FL for boys) 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 moths of screening\n4. History of lifestyle modification to treat obesity or NAFLD\n\nTo be obtained at screening visit:\n\n1. Confirmation of Obesity\n2. Tanner stage 2,3,4 or 5;\n3. Normal fasting glucose tolerance (fasting blood glucose \\\u003C100 mg\u002FdL)\n4. 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 screened 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%\n5. Willingness to adhere to lifestyle considerations throughout the study\n\nExclusion Criteria:\n\n1. ALT \\> 250U\u002FL at screening\n2. History of significant alcohol intake or current use\n3. Impaired fasting glucose (\\>100 mg\u002FdL)\n4. Diabetes (type 1 or 2)\n5. Current or recent (\\\u003C6 months prior to enrollment) use of weight loss medication(s)\n6. Vitamin E supplementation\n7. Previous bariatric surgery\n8. Use of metformin\n9. Prior use of empagliflozin\n10. Lower limb infection\u002Fulceration within 3 months of screening\n11. Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible\n12. Structural and functional urogenital abnormalities, that predispose for urogenital infections\n13. Recent initiation (\\\u003C3 months prior to enrollment) of anti-hypertensive or lipid medication(s)\n14. Major psychiatric disorder\n15. Known hypothalamic or pituitary dysfunction\n16. Current pregnancy or plans to become pregnant\n\n    * Females unwilling to be tested for pregnancy\n    * Females who are sexually active and not protected by an effective method of birth control (e.g. IUD or medication or patch)\n17. Tobacco use\n18. Significant liver dysfunction (levels \\>5 times the upper limit of normal (ULN)):\n\n    * ALT (ULN = 50 U\u002FL)\n    * AST (ULN = 48 U\u002FL)\n    * GGT (ULN = 48 U\u002FL)\n    * ALP (ULN = 115 U\u002FL)\n19. Platelets \\\u003C 150,000 cells\u002Fmm3\n20. Total bilirubin ≥ 1.3 mg\u002FdL\n21. INR ≥ 1.3\n22. Albumin \\\u003C3.2 g\u002FdL\n23. Gilbert's Syndrome\n24. Any known causes of liver disease (except NAFLD and NASH)\n25. Significant renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 80 mL\u002Fmin\u002F1.73 m2),\n26. Diagnosed monogenic obesity\n27. History of cancer\n28. Untreated thyroid disorder\n29. History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)\n30. Current or recent (\\\u003C6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).","12 Years",{"count":20,"type":21},[24],[27,52,53],"NAFLD","Pediatric NAFLD","NOT_YET_RECRUITING","2026-01-16",{"date":29,"type":32},{"date":58,"type":21},"2027-05-01",{"date":36,"type":21},{"name":38,"class":39},""]