Trials
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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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
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
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
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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SPIRE trials: Bococizumab was insufficiently humanized for long-term use
The development of bococizumab, the third of the PCSK9 monoclonal antibodies, was discontinued by Pfizer in early November (1). Insights from a late breaker trial presentation provide some answers why this might be the case. SPIRE programme: lipid lowering trials The SPIRE program included 6…
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SPIRE trials: Bococizumab met primary endpoint in 4 trials
Following on the tails of the first two licensed PCSK9 monoclonal antibodies, there are encouraging early results from Phase III trials with the third PCSK9 monoclonal antibody bococizumab. Topline results from studies in patients with heterozygous familial hypercholesterolemia (SPIRE-FH), high cardiovascular risk (SPIRE-HR), or elevated…
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Phase I study
Trial Phase I trial, reformulated ALN-PCS Aim To investigate the safety, tolerability and LDL cholesterol lowering of ALN-PCSsc (subcutaneous injection) Study design Part A (single dose): Randomised 3:1, Single blind, Placebo controlled designPart B (multi dose): Randomised 6:2, Single blind, Placebo controlled, On or off…
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SPIRE-2
Trial SPIRE-2: Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975389 Aim To evaluate whether bococizumab compared to placebo reduces the occurrrence of major cardiovascular events in high risk subjects who are receiving background…
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SPIRE-1
Cardiovascular outcomes studies with bococizumab Trial SPIRE-1: Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975376 Aim To evaluate whether bococizumab compared to placebo, reduces the occurrence of major cardiovascular events, including cardiovascular death, myocardial…
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SPIRE-LDL
Trial SPIRE-LDL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968967 Aim To assess the efficacy, safety and tolerability of bococizumab to lower LDL-C Study design Multicentre, double-blind, randomized, placebo-controlled, parallel-group study…
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SPIRE-LL
Trial SPIRE-LL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT02100514 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with hyperlipidemia on background statin therapy Study design…
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SPIRE-FH
Trial SPIRE-FH: A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT01968980 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with heterozygous familial hypercholesterolemia Study design Multicentre double-blind, randomized, placebo-controlled,…
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SPIRE-HR
Trial SPIRE-HR: Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects with Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968954 Aim To assess the efficacy, safety and tolerability of Pf-04950615 In subjects with primary hyperlipidemia or mixed dyslipidemia at risk of…
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SPIRE-AI
Trial SPIRE-AI: Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia ClinicalTrials.gov Identifier: NCT02458287 Aim To assess the efficacy, safety, tolerability and subcutaneous administration of bococizumab 150mg and 75mg with a pre-filled pen Study…
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SPIRE-SI
Trial SPIRE-SI: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins ClinicalTrials.gov Identifier: NCT02135029 Aim To demonstrate a superior lipid lowering effect of bococizumab compared to placebo in subjects who are statin intolerant Study design Multicentre, double-blinded, active- and placebo-controlled…
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