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

RecruitingPhase 3

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)

Who can join

Ages 35 to 80 · All sexes

Full eligibility criteria
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).

About the study

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).

What is being tested

Sponsor: Amgen · Participants: 406 · Started: Mar 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07293260

Locations in the U.S.

ConnecticutBridgeport Hospital, Bridgeport
FloridaJacksonville Center for Clinical Research, Jacksonville
KansasMidwest Heart and Vascular Specialists, Overland Park
MarylandFlourish Bowie, Bowie
PennsylvaniaMontefiore Medical Center - Bronx, Philadelphia
TexasVital Heart and Vein, Humble

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.