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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,617
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Percentage Change in LDL-C From Baseline to Day 510
Time frame: Baseline, Day 510
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Time frame: Baseline, Day 90 to Day 540
Absolute Change In LDL-C From Baseline To Day 510
Time frame: Baseline, Day 510
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Time frame: Baseline, Day 90 to Day 540
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Total Cholesterol From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Non-HDL-C From Baseline to Day 510
Time frame: Baseline, Day 510
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site 11420-002
Chomutov, Czechia
Research Site 11420-003
Uherské Hradiště, Czechia
Research Site 11049-006
Berlin, Germany
Research Site 11049-002
Bochum, Germany
Research Site 11049-003
Frankfurt, Germany
Research Site 11049-007
Heidelberg, Germany
Research Site 11049-001
Leipzig, Germany
Research Site 11036-001
Budapest, Hungary
Research Site 11036-004
Debrecen, Hungary
Research Site 11036-002
Hatvan, Hungary
...and 60 more locations