Table 2.
HORIZON (Pelacarsen) | OCEAN(a)-Outcomes (Olpasiran) | |
---|---|---|
Sponsor (Phase) | Novartis (P3) | Amgen (P3) |
Study Design | Randomized double-blind, placebo-controlled, multicenter trial | Randomized double-blind, placebo-controlled, multicenter trial |
Population | Age 18 to 80 years N = 7680 |
Age 18 to 85 years N∼6000 |
Mechanism | Antisense oligonucleotides (ASO) | Small interfering RNA (siRNA) |
Intervention | SC injection Q4 weeks | SC injection Q12 weeks |
Key Inclusion Criteria | Lp(a) ≥ 70 mg/dLCVD, as evidence by either:
|
Lp(a) > 200 nmol/LASCVD, as evidence by either:
|
Primary Endpoint | Cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary revascularization requiring hospitalization (∼4.25 years) | CHD death, MI, urgent coronary revascularization |
Status | Enrollment completed | Enrollment ongoing |
P3=phase 3, SC=subcutaneous, CVD=cardiovascular disease, MI=myocardial infarction, PAD=peripheral arterial disease, PCI=percutaneous coronary intervention.