[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629374":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":11,"responsibleParty":27,"collaborators":11,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":31,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":11},{"fullName":5,"class":6},"Arrowhead Pharmaceuticals","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Zodasiran","EXPERIMENTAL",null,[13],"Drug: Zodasiran",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","By sc injection",[9],[20],"ARO-ANG3",[22],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Medical Monitor","CONTACT","626-304-3400","SPRUCE@arrowheadpharma.com",{"type":28,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100629374","phase-3-study-of-zodasiran-in-adolescent-participants-with-homozygous-familial-hypercholesterolemia-100629374",false,"NCT07473843","Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia","Phase 3 Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent Participants (Age 12 to \u003C18 Years) With Homozygous Familial Hypercholesterolemia (SPRUCE)","SPRUCE","Inclusion Criteria:\n\n* Adolescents 12 to \\\u003C18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study\n* Body weight ≥35 kilograms (kg) at screening\n* HoFH based on a supportive genetic test (from a source-verifiable medical record or based on screening genotype) or clinical diagnosis\n* Screening LDL-C ≥116 mg\u002FdL (3 mmol\u002FL)\n* Screening hemoglobin A1c (HbA1c) ≤9.5%\n* Total bilirubin \\\u003C2×upper limit of normal (ULN), unless in previously confirmed cases of Gilbert's syndrome\n* Alanine aminotransferase or aspartate aminotransferase \\\u003C3×ULN\n\nExclusion Criteria:\n\n* Use of a hepatocyte-targeted siRNA within 365 days before Day 1 (except inclisiran, which is permitted; administration of inclisiran and study drug must be separated by at least 4 weeks)\n* Use of an antisense oligonucleotide molecule within 3 months before Day 1\n* Use of evinacumab within 3 months before Day 1\n* Non-response to evinacumab, defined as LDL-C reduction \\\u003C15% from baseline after 2 doses\n* Use of systemic corticosteroids (unless used as replacement therapy for pituitary\u002Fadrenal disease with a stable regimen)\n\nNOTE: Additional inclusion\u002Fexclusion criteria may apply per protocol","ALL","12 Years","17 Years",{"count":41,"type":42},12,"ESTIMATED","INTERVENTIONAL",[45],"PHASE3","This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to \\\u003C18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and low-density lipoprotein cholesterol (LDL-C) ≥116 milligrams per deciliter (mg\u002FdL) on maximally tolerated lipid-lowering therapy.",[48],"Homozygous Familial Hypercholesterolemia",[50,51,52,53,54,55,56,57,58,59,60,48,9],"Hyperlipoproteinemia Type II","Lipid Metabolism, Inborn Errors","Metabolism, Inborn Errors","Genetic Diseases, Inborn","Congenital, Hereditary, and Neonatal Diseases and Abnormalities","Hyperlipoproteinemias","Hyperlipidemias","Dyslipidemias","Lipid Metabolism Disorders","Metabolic Diseases","Nutritional and Metabolic Diseases","NOT_YET_RECRUITING","2026-05-27",{"date":64,"type":65},"2026-05-29","ACTUAL",{"date":67,"type":42},"2026-08",{"date":69,"type":42},"2028-08",{"name":5,"class":6}]