The double-blind, multicentre, placebo-controlled, randomised, dose-finding Phase II OCEAN(a)-DOSE study was designed for evaluating olpasiran’s tolerability, safety, as well as the optimal dose in atherosclerotic cardiovascular disease (ASCVD) adult patients to reduce lipoprotein(a) levels.
It was conducted in 281 patients with established ASCVD and Lp(a) levels higher than 150 nmol/L.
In the study, the participants were randomised to four doses of olpasiran that includes 10 mg Q12 weeks, 75 mg Q12 weeks, 225 mg Q12 weeks or 225 mg Q24 weeks, or placebo, given subcutaneously.
At week 36, patients who have received 75 mg or more every 12 weeks had reduced Lp(a) levels by more than 95%.
At these doses (75 mg or higher), more than 98% of patients achieved an Lp(a) level of 125 nmol/L or less at week 36.
Injection site reactions, primarily pain, are the most common treatment-related adverse events.
Amgen Research and Development executive vice president David Reese said: “Epidemiological research has shown us that Lp(a) is an independent risk factor and is primarily genetically determined.
“It has been estimated that up to 20% of people worldwide are living with elevated levels, which are linked to a higher risk for heart disease, stroke and the potential significant burden on patients with cardiovascular disease.
“Our Phase II data for olpasiran presented at AHA continue to demonstrate a significant reduction in Lp(a) and provide strong evidence supporting its potential for patients with ASCVD.
“We look forward to studying this treatment further in Phase III clinical trials, which we expect to begin enrolling in December 2022.”