This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
482
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).
Percent Change in LDL-C From Baseline To Day 510
Time frame: Baseline, Day 510
Time-adjusted Percent 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 90 reported
Time frame: Baseline, Day 90
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, absolute change at Day 90 reported
Time frame: Baseline, Day 90
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
Percent Change in Apolipoprotein B (Apo-B) From Baseline To Day 510
Time frame: Baseline, Day 510
Percent Change in Non-high-density Lipoprotein (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.
Site 90001-005
Mission Viejo, California, United States
Site 90001-001
Newport Beach, California, United States
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Site 90001-047
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Site 90001-056
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Site 90001-012
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Site 90001-112
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Cincinnati, Ohio, United States
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