[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648913":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":32,"responsibleParty":76,"collaborators":26,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":35,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Ionis Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Participants aged 12 to \\\u003C18 years will receive multiple doses of olezarsen, at a dose level that depends on body weight, once every month by subcutaneous injection for up to 1 year. All participants may continue to the optional 1-year long-term extension period with the last dose received being after 2 years of treatment.",[13],"Drug: Olezarsen",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Participants aged 2 to \\\u003C12 years will receive multiple doses of olezarsen, at a dose level based on information obtained from Cohort 1, once every month by subcutaneous injection for up to 1 year. All participants may continue to the optional 1-year long-term extension period with the last dose received being after 2 years of treatment.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Olezarsen","Olezarsen will be administered by subcutaneous injection.",[9,15],[25],"ISIS 678354",null,[28],{"name":5,"role":29,"phone":30,"phoneExt":26,"email":31},"CONTACT","(844) 200-6410","IonisOlezarsenPediatric@clinicaltrialmedia.com",[33,47,57,67],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"University of Alabama","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-86.80249,33.52066,{"lat":45,"lon":44},{"facility":48,"status":35,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":26},"UCSF Benioff Children's Hospital","San Francisco","California","94143",{"type":42,"coordinates":53},[54,55],-122.41942,37.77493,{"lat":55,"lon":54},{"facility":58,"status":35,"city":59,"state":60,"zip":61,"country":39,"countryCode":40,"cosmosGeoPoint":62,"geoPoint":66,"contacts":26},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":42,"coordinates":63},[64,65],-96.80667,32.78306,{"lat":65,"lon":64},{"facility":68,"status":35,"city":69,"state":60,"zip":70,"country":39,"countryCode":40,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Cook Children's Medical Center","Fort Worth","76104",{"type":42,"coordinates":72},[73,74],-97.32085,32.72541,{"lat":74,"lon":73},{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100648913","phase-3-a-study-of-olezarsen-for-the-treatment-of-familial-chylomicronemia-syndrome-fcs-in-pediatric-participants-100648913",false,"NCT07727538","A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants","An Open-Label Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Pediatric Patients With Familial Chylomicronemia Syndrome (FCS)","Key Inclusion Criteria:\n\n1. Parental or legally authorized representative consent must be obtained, and the participants must provide age-appropriate or cognition-appropriate assent, as determined by the Investigator. The parent or legal guardian must be able to understand and comply with the study visit schedule and all other study procedures.\n2. Must be able to comply with all study procedures.\n3. Age 12 to less than 18 years at the time of informed consent\u002Fassent (Cohort 1); age 2 to less than 12 years at time of informed consent\u002Fassent (Cohort 2).\n4. Willing to fast for at least 10 hours before visits requiring fasted blood sampling.\n5. A diagnosis of Familial Chylomicronemia Syndrome (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote, compound heterozygote or double heterozygote for loss-of-function mutations in type 1-causing genes.\n6. Fasting TGs ≥880 mg\u002FdL at screening. If fasting TG is \\\u003C 880 mg\u002FdL, up to two additional tests may be performed during the screening period with any single test used to qualify.\n\nKey Exclusion Criteria:\n\n1. Diabetes mellitus with any of the following:\n\n   1. Newly diagnosed within 12 weeks prior to screening or during the screening period.\n   2. Hemoglobin A1c (HbA1c) ≥9.5% at screening.\n   3. Change in basal insulin regimen \\>20% within 3 months prior to screening or during the screening period.\n   4. For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥3 episodes of severe hypoglycemia within 6 months prior to screening or during the screening period.\n2. History of bleeding, diathesis, or coagulopathy.\n3. Major surgery within 3 months of screening.\n4. Plasma apheresis within 4 weeks prior to screening or planned during the study.\n5. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer.\n6. Active pancreatitis within 4 weeks prior to screening or during the screening period.\n7. Malignancy diagnosed or treated within 5 years prior to screening or during the screening period.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.","ALL","2 Years","17 Years",{"count":89,"type":90},12,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The primary purpose of the study is to evaluate the efficacy of olezarsen administered by subcutaneous injection to pediatric participants with FCS.",[96],"Familial Chylomicronemia Syndrome","2026-08-14",{"date":99,"type":100},"2026-08-18","ACTUAL",{"date":102,"type":100},"2026-07-31",{"date":104,"type":90},"2031-08",{"name":5,"class":6},4]