Basic Information

Gene symbol PCSK9 Synonyms FH3, FHCL3, HCHOLA3, LDLCQ1, NARC-1, NARC1, PC9 Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas
Description proprotein convertase subtilisin/kexin type 9

GTO ID GTC0357
Trial ID NCT03060577
Disease Arteriosclerotic Cardiovascular Disease | Atherosclerosis | Type 2 Diabetes Mellitus | Familial Hypercholesterolemia
Altered gene PCSK9
Therapeutic/Target gene Target gene
TherapysiRNA
Treatment ALN-PCSSC|Inclisiran|KJX839|Leqvio
Location approved EU, UK, Australia, Canada, Israel, US, Saudi Arabia, Japan, China
PhasePhase2
Recruitment statusCompleted
TitleAn Open Label, Active Comparator Extension Trial to Assess the Effect of Long Term Dosing of Inclisiran and Evolocumab Given as Subcutaneous Injections in Participants With High Cardiovascular Risk and Elevated LDL-C (ORION-3)
Year2017
CountryCanada|Germany|Netherlands|United Kingdom|United States
Company sponsorNovartis Pharmaceuticals
Other ID(s)MDCO-PCS-16-01|2016-003815-37
Vector information
VectorGalNAc

Clinical Result

Cohort1: Inclisiran_dose Day 1
Administration route subcutaneous injection
Dosage 300 mg, Day 1 and every 180 days thereafter up to Year 4
Pts 284
Age Adult, Older_Adult
Adverse reactions 7/284(All-cause mortality); 104/284(Blood and lymphatic system disorders; Cardiac disorders; Ear and labyrinth disorders; Eye disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Vascular disorders)
References PMID: 36620965
Cohort2: evolocumab
Administration route subcutaneous injection
Dosage evolocumab, 140 mg, every 14 days thereafter until Day 336
Pts 90
Age Adult, Older_Adult
Adverse reactions 0/90(All-cause mortality); 16/90(Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders)
References PMID: 36620965
Cohort3: Inclisiran_dose Day 360
Administration route subcutaneous injection
Dosage 300 mg, Day 360 and every 180 days thereafter up to Year 4
Pts 87
Age Adult, Older_Adult
Adverse reactions 1/87(All-cause mortality); 30/87(Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Investigations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Reproductive system and breast disorders; Vascular disorders)
References PMID: 36620965

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