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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-8

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

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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ORION-13

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

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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V-MONO

V-MONO

Study title/design: V-MONO: inclisiran monotherapy in primary hypercholesterolaemia (NCT05763875) Trial NCT05763875 (Completed) Aim To determine if inclisiran can effectively reduce LDL-C compared to ezetimibe and placebo. Study design Phase 3, double-blind, placebo- and active comparator controlled trial of inclisiran 284 mg s.c. on day 1…

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VICTORION-CHALLENGE

VICTORION-CHALLENGE

Study title/design: VICTORION-CHALLENGE: comparison of bempedoic acid and inclisiran on LDL-C lowering (NCT06431763) Trial NCT06431763 (Recruiting). Estimated primary completion: 1 September 2025. Estimated study completion: 30 September 2025. Aim To evaluate the efficacy of bempedoic acid and inclisiran on LDL-C lowering in participants with atherosclerotic…

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VICTORION-2 PREVENT

VICTORION-2 PREVENT

Study title/design: VICTORION-2 PREVENT: inclisiran to prevent CV events in established CV disease (NCT05030428) Trial NCT05030428 (Active, not recruiting). Estimated primary completion: 13 October 2027. Estimated study completion: 13 October 2027. Aim To determine if inclisiran in addition to well tolerated, high intensity statin therapy,…

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VICTORION-1 PREVENT

VICTORION-1 PREVENT

Study title/design: VICTORION-1 PREVENT: inclisiran to prevent CV events in high risk primary prevention (NCT0573983) Trial NCT0573983 (Recruiting). Estimated primary completion: 16 April 2029. Estimated study completion: 16 April 2029. Aim To determine if inclisiran can significantly reduce major adverse cardiovascular events (MACE) in patients…

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