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A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

Matsumoto Hiroki

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Recruiting

Mar. 21, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Age 35 to <= 80 years.
2. Lp(a) >= 200 nmol/L during screening.
3. Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
4. History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.

1. History of coronary artery bypass graft (CABG).
2. Moderate to severe renal dysfunction.
3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening.
4. History of hemorrhagic stroke.
5. History of major bleeding disorder.
6. Planned cardiac surgery or arterial revascularization.
7. Severe heart failure.
8. Current, recent, or planned lipoprotein apheresis.
9. Previously received ribonucleic acid therapy specifically targeting Lp(a).

Both

Cardiovascular Disease

Experimental: Olpasiran
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Interventions: Drug: Olpasiran

Placebo Comparator: Placebo
Participants will receive placebo SC Q12W.
Interventions: Drug: Placebo

1. Change in NCP Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72]

1. Change in Low Attenuation Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72]
2. Change in Total Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72]
3. Change in Calcified Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week72]
4. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to Week 74]

Oct. 15, 2025

Yes

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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