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 GTC0414
Trial ID NCT03400800
Disease Arteriosclerotic Cardiovascular Disease | 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
PhasePhase3
Recruitment statusCompleted
TitleA Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Year2017
CountryCzechia|Germany|Hungary|Poland|South Africa|Ukraine|United Kingdom
Company sponsorThe Medicines Company
Other ID(s)MDCO-PCS-17-08
Vector information
VectorGalNAc

Clinical Result

Cohort1: Inclisiran
Administration route subcutaneous injection
Dosage Inclisiran sodium, 300mg/1.5mL, Day 1, Day 90, then every 6 months
Pts 810
Age Adult, Older_Adult
Outcome Percentage Change in LDL-C From Baseline to Day 510：-49.3|Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540:-45.82
Adverse reactions 14/811(All-cause mortality); 181/811(Blood and lymphatic system disorders; Cardiac disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Immune system 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; Product Issues; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Surgical and medical procedures; Vascular disorders)
References PMID: 32187462 | 37282500
Cohort2: Saline Solution
Administration route subcutaneous injection
Dosage Saline Solution, 300mg/1.5mL, Day 1, Day 90, then every 6 months
Pts 807
Age Adult, Older_Adult
Outcome Percentage Change in LDL-C From Baseline to Day 510：4.2|Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540:3.35
Adverse reactions 15/804(All-cause mortality); 181/804(Blood and lymphatic system disorders; Cardiac disorders; Ear and labyrinth disorders; Gastrointestinal disorders; General disorders; Hepatobiliary 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; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 32187462 | 37282500

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