{"id":"nct:NCT06597019","kind":"trial","title":"Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia","authors":["Novartis Pharmaceuticals"],"author_count":1,"year":2024,"published":"2024-09-19","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT06597019","source_url":"https://clinicaltrials.gov/study/NCT06597019","archive_url":"https://space-kitty.com/papers/nct:NCT06597019","updated":"2026-05-15","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \\<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Familial Hypercholesterolemia - Heterozygous"],"details":{"acronym":"ORION-20","status":"RECRUITING","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":60,"sponsor":"Novartis Pharmaceuticals","conditions":["Familial Hypercholesterolemia - Heterozygous"],"interventions":["DRUG: Inclisiran","DRUG: Placebo"],"start_date":"2024-12-09","start_date_type":"ACTUAL","primary_completion_date":"2028-03-21","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"cardiovascular-innovation","name":"Cardiovascular Therapeutics","domain_slug":"medicine"}],"cited_in_dossiers":[]}