Inclisiran
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
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
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
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
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
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-8
Trial Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8) ClinicalTrials.gov Identifier: NCT03814187 Aim To evaluate the efficacy, safety, and tolerability of long-term dosing of inclisiran. Study Design Global multicentre, open label, long…
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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
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
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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ORION-13
Trial Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia (ORION-13). ClinicalTrials.gov Identifier: NCT04659863 Aim To investigate the efficacy, safety, and tolerability of inclisiran in adolescents diagnosed with homozygous familial hypercholesterolaemia (HoFH). Study Design Two-part (1 year double-blind inclisiran versus…
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ORION-16
Trial Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia (ORION-16). ClinicalTrials.gov Identifier: NCT04652726 Aim To investigate the efficacy, safety, and tolerability of inclisiran in adolescents diagnosed with heterozygous familial hypercholesterolaemia (HeFH). Study Design Two-part (1 year double-blind inclisiran versus…
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