RNA therapeutics
The OCEAN(a)-DOSE trial enrolls 281 patients to find olpasiran optimal dose ahead of a cardiovascular outcomes trial (Am Heart J 2022)
Original title: Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE)
This paper describes the design and rationale of the OCEAN(a)-DOSE trial, a multicentre, randomised, double-blind, placebo-controlled dose-finding study of olpasiran, a small interfering RNA that markedly reduces hepatic Lp(a) production, in 281 subjects with established atherosclerotic cardiovascular disease and Lp(a) >150 nmol/L. Patients were randomised to one of four active subcutaneous olpasiran regimens (10 mg every 12 weeks, 75 mg every 12 weeks, 225 mg every 12 weeks, or 225 mg every 24 weeks) or matched placebo, with the primary objective of comparing percent change in Lp(a) from baseline at 36 weeks between the every-12-weeks doses and placebo. Enrolment is complete and follow-up ongoing. The trial dosing data will inform the design of a subsequent cardiovascular outcomes trial for olpasiran.
Original abstract
Background: Data support lipoprotein(a) (Lp[Lp(a)]) being a risk factor for atherosclerotic cardiovascular disease (ASCVD). Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes.
Study Design: The Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study is a multicenter, randomized, double-blind, placebo-controlled dose-finding study in 281 subjects with established ASCVD and Lp(a) > 150 nmol/L. Patients were randomly allocated to one of 4 active subcutaneous doses of olpasiran (10 mg q12 weeks, 75 mg q12 weeks, 225 mg q 12 weeks, or 225 mg q24 weeks) or matched placebo. The primary objective is to evaluate the effects of olpasiran dosed every 12 weeks compared with placebo on the percent change in Lp(a) from baseline at 36 weeks. Enrollment is now complete and follow-up is ongoing.
Conclusions: 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.
olpasiranphase 2RNA therapeutics
Summary written by lp-a.org from the published abstract; figures as published. Page updated 18 August 2026. Methods.