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

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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07293260

Acronym

OCEAN(a)-CCTA

Enrollment

406

Registered

2025-12-19

Start date

2026-03-23

Completion date

2028-06-15

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Stable Atherosclerotic Cardiovascular Disease, Elevated Lipoprotein(a), Coronary Artery Plaque Burden, Olpasiran

Brief summary

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Interventions

DRUGOlpasiran

Olpasiran will be administered SC.

DRUGPlacebo

Placebo will be administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age 35 to ≤ 80 years. * 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

* History of coronary artery bypass graft (CABG). * 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).

Design outcomes

Primary

Measure	Time frame
Change in NCP Volume from Baseline to Week 72	Baseline to Week 72

Secondary

Measure	Time frame
Change in Low Attenuation Plaque Volume from Baseline to Week 72	Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72	Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72	Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to Week 74

Countries

Australia, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United States

Contacts

CONTACTAmgen Call Center

medinfo@amgen.com866-572-6436

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026