{"id":"nct:NCT03400800","kind":"trial","title":"Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol","authors":["The Medicines Company"],"author_count":1,"year":2018,"published":"2018-01-17","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT03400800","source_url":"https://clinicaltrials.gov/study/NCT03400800","archive_url":"https://space-kitty.com/papers/nct:NCT03400800","updated":"2020-08-21","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).","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,"peer_reviewed":null,"categories":["ASCVD","Risk Factor, Cardiovascular","Elevated Cholesterol"],"details":{"acronym":"ORION-11","status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":1617,"sponsor":"The Medicines Company","conditions":["ASCVD","Risk Factor, Cardiovascular","Elevated Cholesterol"],"interventions":["DRUG: Inclisiran Sodium","DRUG: Placebo"],"start_date":"2017-11-01","start_date_type":"ACTUAL","primary_completion_date":"2019-07-31","has_results":true,"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":[]}