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Inclisiran

ORION-1

ORION-1

ORION-1 Trial A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C  Aim Primary: To evaluate the effect of ALN-PCSSC treatment on LDL-C levels at…

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ORION-2

ORION-2

Trial A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (ORION-2) ClinicalTrials.gov Identifier: NCT02963311 Aim To assess the safety, tolerability, and efficacy of inclisiran in participants with homozygous familial hypercholesterolemia (FH) Study Design Open-Label, Single-Arm, Multicenter Pilot Study Patient population 10 patients with homozygous…

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ORION-3

ORION-3

Trial An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol ClinicalTrials.gov Identifier: NCT03060577 Aim To assess the effect of long term dosing of Inclisiran and Evolocumab in patients with high cardiovascular risk and elevated LDL-C Study Design Long-term…

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HPS-4/TIMI 65 ORION-4

HPS-4/TIMI 65 ORION-4

Trial HPS-4/TIMI 65 ORION-4: Cardiovascular outcomes study Aim To assess the effect of inclisiran on major cardiovascular events Study design Randomised, double-blind, placebo-controlled. Patients will be randomised to treatment with inclisiran sodium 300 mg or matching placebo for a median of about 5 years.  Treatment…

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ORION-5

ORION-5

Trial A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5) ClinicalTrials.gov Identifier: NCT03851705 Aim To evaluate the safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH) Study Design Multicentre Phase III study conducted in two parts; double-blind placebo-controlled…

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ORION-7

ORION-7

Trial A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function ClinicalTrials.gov Identifier: NCT03159416 Aim To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and…

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ORION-9

ORION-9

Trial Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9) ClinicalTrials.gov Identifier: NCT03397121 Aim To evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran in patients with heterozygous familial…

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ORION-10

ORION-10

Trial Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10) ClinicalTrials.gov Identifier: NCT03399370 Aim To Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated LDL-C Study Design Phase…

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ORION-11

ORION-11

Trial Inclisiran for Subjects With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-11) ClinicalTrials.gov Identifier: NCT03400800 Aim To Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)…

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