[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06355310":3,"trial-entities:NCT06355310":138,"trial-summary:NCT06355310":142},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":43,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":110,"locations":113,"central_contacts":132,"overall_officials":134,"references":136,"see_also_links":137},"NCT06355310","IRB 2023-6429","Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease","RECRUITING","2028-02-01","2026-01","2026-01-21","2025-04-10","Justin Ryder","OTHER",true,"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.","The overall aim of this pilot study is to evaluate the feasibility and obtain a preliminary estimate of efficacy and safety of the SGLT2 inhibitor, empagliflozin, in adolescents with obesity (BMI-percentile ≥95th) who have MRI-confirmed NAFLD (hepatic fat fraction ≥ 5.5%) and have normal fasting glucose.\n\nParticipants will take empagliflozin, once daily, in the morning, with or without food, in addition to receiving lifestyle\u002Fbehavioral counseling throughout the study.\n\nThe following data will be collected throughout the course of the study: Physical exam with tanner staging, safety and fasting labs, fasting blood draw (biomarkers), urine sample, 2-stage clamp (overnight Stay),Stable isotope tracers (overnight Stay), MRI scan (MRS-Liver), BMI\u002Fanthropometrics, urine pregnancy test for female participants, iDXA scan (body fat and bone density), arterial stiffness and blood pressure.",[18],"Non-Alcoholic Fatty Liver Disease",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},40,"ESTIMATED",[28,36],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"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)",[33],"Study intervention",[35],"Jardiance",{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"Placebo Oral Tablet","Participants will take an identical appearing oral tablet with zero active ingredient.",[40],"Control arm",[42],"Control group",[44],{"measure":45,"description":46,"timeFrame":47},"Hepatic Fat","change in hepatic fat fraction (Hepatic fat will be measured by MRI via proton density fat fraction (PDFF)) from baseline (first measurement time point) to 26-weeks.","26-Weeks",[49],{"measure":50,"description":51,"timeFrame":47},"Body mass index","* BMI\n* body fat% (total and visceral fat)\n* ALT\n* biomarkers of NAFLD oCK-18 ototal and activated PAI-1 oIL-8\n* biomarkers of bone health (additional safety outcome) oN-terminal collagen type I extension propeptide (PINP) oOsteocalcin oC-terminal cross-linking telopeptide of type I collagen (CTX)\n* Systolic and diastolic blood pressure\n* glycemic control (from oral glucose tolerance test)\n* Insulin sensitivity (from oral glucose tolerance test) by the whole-body insulin sensitivity index","ALL","16 Years","20 Years",false,{"inclusion":57,"exclusion":71,"raw_text":109},[58,59,60,61,62,63,64,65,66,67,68,69,70],"BMI \\>30 kg\u002Fm2 or \\>95th BMI-Percentile","Weight Range of 75kg to 150kg","Age 16 to \\\u003C21 at baseline","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.","History of lifestyle modification to treat obesity or NAFLD.","Tanner stage \\>2","Normal fasting glucose (fasting blood glucose \\\u003C100 mg\u002FdL)","Confirmation of obesity;","Tanner stage 2,3,4 or 5;","Normal fasting glucose tolerance (fasting blood glucose \\\u003C100 mg\u002FdL);","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",[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"ALT \\> 250U\u002FL at screening","History of significant alcohol intake or current use","Impaired fasting glucose (\\>100 mg\u002FdL)","Diabetes (type 1 or 2)","Current or recent (\\\u003C6 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\u002Fulceration 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 (\\\u003C3 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\u002FL)","AST (ULN = 48 U\u002FL)","GGT (ULN = 48 U\u002FL)","ALP (ULN = 115 U\u002FL)","Platelets \\\u003C 150,000 cells\u002Fmm3","Total bilirubin \\> 1.3 mg\u002FdL","INR \\> 1.3","Albumin \\\u003C3.2 g\u002FdL","Gilbert's Syndrome","Any known causes of liver disease (except NAFLD and NASH)","Significant renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 80 mL\u002Fmin\u002F1.73 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 (\\\u003C6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).","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).",[111,112],"CHILD","ADULT",[114],{"facility":115,"status":7,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":129},"Ann & Robert H Lurie Children's Hospital of Chicago","Chicago","Illinois","60611","United States",[121,126],{"name":122,"role":123,"phone":124,"email":125},"Farah Salim, M.S.","CONTACT","773-550-0749","SHIELD@luriechildrens.org",{"name":127,"role":128},"Justin Ryder, PhD","PRINCIPAL_INVESTIGATOR",{"lat":130,"lon":131},41.85003,-87.65005,[133],{"name":122,"role":123,"phone":124,"email":125},[135],{"name":127,"affiliation":115,"role":128},[],[],{"nct_id":4,"conditions":139,"biomarkers":141},[140],"Nonalcoholic Fatty Liver Disease",[],{"nct_id":4,"found":14,"summary":143,"prompt_version":153},{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is a randomized, double-blind, placebo-controlled study with 40 participants. This means participants are randomly assigned to receive either empagliflozin or a placebo, and neither you nor the study team will know which you are receiving.","completed","Empagliflozin for Pediatric Steatotic Liver Disease","This study is looking into how well and how safely a medication called empagliflozin works for adolescents (ages 16 to 20) who have non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where too much fat builds up in the liver. Participants will either take a 10 mg empagliflozin tablet or a placebo (an inactive pill that looks the same) once daily. The main goal is to see if empagliflozin can reduce the amount of fat in the liver after 26 weeks. To join, you need to be between 16 and 20 years old, have a high BMI (Body Mass Index), and elevated liver enzymes (ALT). The study status is currently unclear.","The primary endpoint for measuring liver fat is at 26 weeks, which suggests follow-up will occur at least until this time.",112,"Participants will take a daily pill and receive lifestyle counseling. You will have physical exams, blood draws, urine samples, an overnight stay for special tests, MRI scans, and body fat measurements.","Not stated in the trial record.",[],"v2"]