Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial
NCT ID: NCT07293260
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
406 participants
INTERVENTIONAL
2026-03-21
2028-06-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Olpasiran
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Olpasiran
Olpasiran will be administered SC.
Placebo
Participants will receive placebo SC Q12W.
Placebo
Placebo will be administered SC.
Interventions
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Olpasiran
Olpasiran will be administered SC.
Placebo
Placebo will be administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lp(a) ≥ 200 nmol/L during screening.
* Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
* History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.
Exclusion Criteria
* Moderate to severe renal dysfunction.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening.
* History of hemorrhagic stroke.
* History of major bleeding disorder.
* Planned cardiac surgery or arterial revascularization.
* Severe heart failure.
* Current, recent, or planned lipoprotein apheresis.
* Previously received ribonucleic acid therapy specifically targeting Lp(a).
35 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230191
Identifier Type: -
Identifier Source: org_study_id