ALN-PCSsc
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 I: Durability of response with PCSK9 RNA interference agent
The first in class PCSK9 RNA interference agent, inclisiran (previously known as ALN-PCSsc) showed sustained lowering of low-density lipoprotein cholesterol (LDL-C) on top of the standard of care including statins, according to early results from the ORION-1 study. Until recently, the main focus of therapeutic…
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ORION I steams ahead
ORION I steams ahead This Phase II trial with the first-in-class RNA interference (RNAi) PCSK9 inhibitor (ALN-PCSsc) has now completed patient recruitment. Interim results (both efficacy and safety) from this dose ranging study are expected late in 2016. The trial is being run at 54…
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Phase II studies
ALN-PCSsc ORION programme This programme with the first-in-class RNA interference (RNAi) PCSK9 inhibitor ALN-PCSsc was launched with the ORION-1 study. Trial ORION-1: Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) ClinicalTrials.gov Identifier: NCT02597127 Aim To evaluate the efficacy, safety,…
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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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