Study Design and Rationale for the OCEAN(a)-DOSE (Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction-DOSE Finding Study) Trial

Data support lipoprotein(a) [Lp(a)] being a risk factor for atherogenesis. Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes. The OCEAN(a)-DOSE trial is a multicenter, randomized, double-blind, placebo-controlled dose-finding study in 281 subjects wi...

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Bibliographic Details
Published inThe American heart journal
Main Authors O'Donoghue, Michelle L, López, J Antonio G, Knusel, Beat, Gencer, Baris, Wang, Huei, Wu, You, Kassahun, Helina, Sabatine, Marc S
Format Journal Article
LanguageEnglish
Published United States 06.05.2022
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Summary:Data support lipoprotein(a) [Lp(a)] being a risk factor for atherogenesis. Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes. The OCEAN(a)-DOSE trial is a multicenter, randomized, double-blind, placebo-controlled dose-finding study in 281 subjects with established atherosclerotic disease and Lp(a) >150 nmol/L. Patients were randomly allocated to one of 4 active subcutaneous doses of olpasiran (10mg q12 weeks, 75mg q12 weeks, 225mg q12 weeks or 225mg q24 weeks) or matched placebo. The primary objective is to evaluate the effects of olpasiran dosed every 12 weeks compared with placebo on the mean percent change in Lp(a) from baseline at 36 weeks. Enrollment is now complete and follow-up is ongoing. The OCEAN(a)-DOSE trial is assessing the Lp(a)-lowering efficacy and safety of olpasiran. These data will be used to determine optimal dosing and design for a cardiovascular outcomes trial. This study was funded by Amgen. (ClinicalTrials.gov NCT04270760).
ISSN:1097-6744