This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD 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 a multicenter study in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,561
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 Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
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
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
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 10001-015
Birmingham, Alabama, United States
Research Site 10001-138
Foley, Alabama, United States
Research Site 10001-113
Huntsville, Alabama, United States
Research Site 10001-058
Mobile, Alabama, United States
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Montgomery, Alabama, United States
Research Site 10001-076
Saraland, Alabama, United States
Research Site 10001-013
Chandler, Arizona, United States
Research Site 10001-077
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Research Site 10001-136
Phoenix, Arizona, United States
Research Site 10001-051
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...and 135 more locations