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Olpasiran

Phase 3

Atherosclerotic Cardiovascular Disease | Small molecule | Other |Amgen Inc.|Last Updated: Feb 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment7,297
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05581303Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes TrialPHASE3 ACTIVE NOT_RECRUITING 7,297 — — Dec 14, 2022Mar 31, 2028Feb 27, 2026737 United States, Argentina +32
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Study Endpoints
Primary Endpoints
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Approximately 5 years
Secondary Endpoints
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
Approximately 5 years
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Approximately 5 years
Percent change from baseline to Week 48 in Lipoprotein(a)
Baseline and Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo will be administered by subcutaneous injection.
OlpasiranEXPERIMENTALOlpasiran will be administered by subcutaneous injection.
Interventions
NameTypeDescription
PlaceboDRUGPlacebo given by subcutaneous injection once every 12 weeks (Q12W).
OlpasiranDRUGOlpasiran given by subcutaneous injection Q12W.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites737

Inclusion Criteria: * Age 18 to ≤ 85 years * Lp(a) ≥ 200 nmol/L during screening * History of ASCVD as evidenced by history of either: * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or * Coronary revascularization with percutaneous coronary intervention AND a...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChinaCzechiaDenmarkEstoniaFinlandFranceGermanyGreeceHong KongHungaryIcelandItalyJapanLithuaniaMexicoNetherlandsNorwayPolandPortugalRomaniaSlovakiaSouth KoreaSpainSwedenTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05581303primaryCompletionDate: changed
LOWMay 24, 2026NCT05581303studyFirstPostDate: changed