[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07477704":3,"trial-entities:NCT07477704":348,"trial-summary:NCT07477704":352},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":48,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":77,"locations":80,"central_contacts":336,"overall_officials":342,"references":346,"see_also_links":347},"NCT07477704","R727-CL-2553","A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia","A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia","RECRUITING","2027-02-23","2026-07","2026-07-22","2026-06-17","Regeneron Pharmaceuticals","INDUSTRY",false,"This study is researching an experimental drug called alirocumab, referred to as \"study drug\". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).\n\nThe aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug once a week\n* How much study drug is in the blood at different times",null,[19],"Hypercholesterolemia",[21,22],"Obesity","Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},420,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":40},"DRUG","Alirocumab","Administered per the protocol",[36,37,38,39],"Arm 1 - Low Dose","Arm 2 - Medium Dose","Arm 3 - High Dose","Arm 4 - Control Dose",[41,42,43],"Praluent®","REGN727","SAR236553",[45],{"measure":46,"timeFrame":47},"Percent change in LDL-C","From Baseline through Week 12",[49,52,54,56,58,60,62,64,66,68],{"measure":50,"timeFrame":51},"Concentrations of total alirocumab in serum","Through Week 20",{"measure":53,"timeFrame":51},"Concentrations of free Proprotein Convertase Subtilisin\u002FKexin type 9 (PCSK9) in serum",{"measure":46,"timeFrame":55},"From Baseline through Week 8",{"measure":57,"timeFrame":47},"Percent change in total cholesterol",{"measure":59,"timeFrame":47},"Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)",{"measure":61,"timeFrame":47},"Percent change in HDL-C",{"measure":63,"timeFrame":47},"Percent change in triglycerides",{"measure":65,"timeFrame":47},"Percent change in Apolipoprotein B (ApoB)",{"measure":67,"timeFrame":51},"Occurrence of Treatment-Emergent Adverse Events (TEAEs)",{"measure":69,"timeFrame":51},"Severity of TEAEs","ALL","18 Years","80 Years",{"inclusion":74,"exclusion":75,"raw_text":76},[],[],"Key Inclusion Criteria:\n\n1\\. Participant has elevated LDL-C level, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant plans to initiate or change dose of lipid-lowering therapy\n2. Use of any PCSK9 inhibitors\n\nNOTE: Other Protocol-Defined Inclusion\u002FExclusion Criteria Apply",[78,79],"ADULT","OLDER_ADULT",[81,90,97,105,112,119,127,134,141,148,156,163,171,179,187,195,203,211,219,226,234,242,249,257,265,273,280,288,295,302,309,313,320,328],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Pinnacle Research Group","Anniston","Alabama","36207","United States",{"lat":88,"lon":89},33.65983,-85.83163,{"facility":91,"status":8,"city":92,"state":84,"zip":93,"country":86,"geoPoint":94},"Cullman Clinical Trials","Cullman","35055",{"lat":95,"lon":96},34.17482,-86.84361,{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":86,"geoPoint":102},"Anaheim Clinical Trials","Anaheim","California","92801",{"lat":103,"lon":104},33.83529,-117.9145,{"facility":106,"status":8,"city":107,"state":100,"zip":108,"country":86,"geoPoint":109},"Cenexel CNS","Los Alamitos","90720",{"lat":110,"lon":111},33.80307,-118.07256,{"facility":113,"status":8,"city":114,"state":100,"zip":115,"country":86,"geoPoint":116},"Diablo Clinical Research - Flourish Research","Walnut Creek","94598",{"lat":117,"lon":118},37.90631,-122.06496,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":86,"geoPoint":124},"Tampa Bay Medical Research","Clearwater","Florida","33761",{"lat":125,"lon":126},27.96585,-82.8001,{"facility":128,"status":8,"city":129,"state":122,"zip":130,"country":86,"geoPoint":131},"Southwest General Healthcare Center","Fort Myers","33907",{"lat":132,"lon":133},26.62168,-81.84059,{"facility":135,"status":8,"city":136,"state":122,"zip":137,"country":86,"geoPoint":138},"Precision Clinical Research","Sunrise","33351",{"lat":139,"lon":140},26.13397,-80.1131,{"facility":142,"status":8,"city":143,"state":122,"zip":144,"country":86,"geoPoint":145},"K2 Medical Research The Villages","The Villages","32159",{"lat":146,"lon":147},28.93408,-81.95994,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":86,"geoPoint":153},"Center for Advanced Research and Education","Gainesville","Georgia","30501",{"lat":154,"lon":155},34.29788,-83.82407,{"facility":157,"status":8,"city":158,"state":151,"zip":159,"country":86,"geoPoint":160},"Balanced Life Health Care Solutions","Lawrenceville","30046",{"lat":161,"lon":162},33.95621,-83.98796,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":86,"geoPoint":168},"East-West Medical Research Institute","Honolulu","Hawaii","96814",{"lat":169,"lon":170},21.30694,-157.85833,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":86,"geoPoint":176},"L-MARC Research Center","Louisville","Kentucky","40213",{"lat":177,"lon":178},38.25424,-85.75941,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":86,"geoPoint":184},"Tandem Clinical Research","Marrero","Louisiana","70072",{"lat":185,"lon":186},29.89937,-90.10035,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":86,"geoPoint":192},"Mercury Street Medical Group, PLLC","Butte","Montana","59701",{"lat":193,"lon":194},46.00382,-112.53474,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":86,"geoPoint":200},"Velocity Clinical Research - Omaha","Omaha","Nebraska","68134",{"lat":201,"lon":202},41.25626,-95.94043,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":86,"geoPoint":208},"Palm Research Center, Mountainview Medical Center","Las Vegas","Nevada","89128",{"lat":209,"lon":210},36.17497,-115.13722,{"facility":212,"status":8,"city":213,"state":214,"zip":215,"country":86,"geoPoint":216},"Velocity Clinical Research - Durham","Durham","North Carolina","27701",{"lat":217,"lon":218},35.99403,-78.89862,{"facility":220,"status":8,"city":221,"state":214,"zip":222,"country":86,"geoPoint":223},"Accellacare of Wilmington","Wilmington","28401",{"lat":224,"lon":225},34.23556,-77.94604,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":86,"geoPoint":231},"Ohio Clinical Trials","Columbus","Ohio","43212",{"lat":232,"lon":233},39.96118,-82.99879,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":86,"geoPoint":239},"AMR Norman","Norman","Oklahoma","73069",{"lat":240,"lon":241},35.22257,-97.43948,{"facility":243,"status":8,"city":244,"state":237,"zip":245,"country":86,"geoPoint":246},"Lynn Health Science Institute","Oklahoma City","73112",{"lat":247,"lon":248},35.46756,-97.51643,{"facility":250,"status":8,"city":251,"state":252,"zip":253,"country":86,"geoPoint":254},"Velocity Clinical Research, Medford","Medford","Oregon","97504",{"lat":255,"lon":256},42.32652,-122.87559,{"facility":258,"status":8,"city":259,"state":260,"zip":261,"country":86,"geoPoint":262},"Altoona Center for Clinical Research","Duncansville","Pennsylvania","16635",{"lat":263,"lon":264},40.42341,-78.4339,{"facility":266,"status":8,"city":267,"state":268,"zip":269,"country":86,"geoPoint":270},"Tribe Clinical Research","Greenville","South Carolina","29607",{"lat":271,"lon":272},34.85262,-82.39401,{"facility":274,"status":8,"city":275,"state":268,"zip":276,"country":86,"geoPoint":277},"Coastal Carolina Research Center_North Charleston","North Charleston","29405",{"lat":278,"lon":279},32.85462,-79.97481,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":86,"geoPoint":285},"Velocity Clinical Research Dallas","Dallas","Texas","75230",{"lat":286,"lon":287},32.78306,-96.80667,{"facility":289,"status":8,"city":290,"state":283,"zip":291,"country":86,"geoPoint":292},"Valley Institute of Research, Rockwood Medical Clinic","Fort Worth","76164",{"lat":293,"lon":294},32.72541,-97.32085,{"facility":296,"status":8,"city":297,"state":283,"zip":298,"country":86,"geoPoint":299},"Be Well Clinical Studies - Round Rock","Round Rock","78681",{"lat":300,"lon":301},30.50826,-97.6789,{"facility":303,"status":8,"city":304,"state":283,"zip":305,"country":86,"geoPoint":306},"Flourish Research - San Antonio Medical Trials","San Antonio","78229",{"lat":307,"lon":308},29.42412,-98.49363,{"facility":310,"status":8,"city":304,"state":283,"zip":311,"country":86,"geoPoint":312},"Endeavor Clinical Trials","78240",{"lat":307,"lon":308},{"facility":314,"status":8,"city":315,"state":283,"zip":316,"country":86,"geoPoint":317},"Consano Clinical Research, LLC","Shavano Park","78231",{"lat":318,"lon":319},29.58495,-98.55252,{"facility":321,"status":8,"city":322,"state":323,"zip":324,"country":86,"geoPoint":325},"Charlottesville Medical Research","Charlottesville","Virginia","22911",{"lat":326,"lon":327},38.02931,-78.47668,{"facility":329,"status":8,"city":330,"state":331,"zip":332,"country":86,"geoPoint":333},"Rainier Clinical Research Center","Renton","Washington","98057",{"lat":334,"lon":335},47.48288,-122.21707,[337],{"name":338,"role":339,"phone":340,"email":341},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[343],{"name":344,"affiliation":13,"role":345},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":349,"biomarkers":350},[19,21],[351],"Proprotein Convertase Subtilisin\u002FKexin Type 9",{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]