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Olpasiran to lower lipoprotein(a) and shrink non-calcified coronary plaque

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)

PHASE3 · Amgen · NCT07293260

This trial will test whether olpasiran can lower very high Lp(a) and reduce non-calcified coronary plaque in adults 35–80 with prior heart attack or coronary revascularization.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment406 (estimated)
Ages35 Years to 80 Years
SexAll
SponsorAmgen (industry)
Locations40 sites (Bridgeport, Connecticut and 39 other locations)
Trial IDNCT07293260 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized interventional trial compares olpasiran versus placebo in adults with stable atherosclerotic cardiovascular disease and markedly elevated Lp(a) (≥200 nmol/L). Participants must have angiographic evidence of coronary artery disease on coronary CT angiography (CCTA) and a history of myocardial infarction or prior percutaneous coronary intervention. The primary endpoint is change in non-calcified plaque (NCP) volume measured by CCTA, with participants receiving olpasiran injections or matched placebo over the study period. Key exclusions include prior CABG, significant renal or liver dysfunction, bleeding disorders, recent or planned lipoprotein apheresis, and prior RNA therapies specifically targeting Lp(a).

Who should consider this trial

Good fit: Ideal candidates are adults aged 35–80 with stable coronary artery disease, a history of myocardial infarction or PCI, Lp(a) ≥200 nmol/L, and CCTA evidence of coronary plaque.

Not a fit: Patients with prior coronary bypass, severe heart failure, significant kidney or liver dysfunction, bleeding disorders, or who already receive Lp(a) apheresis or prior Lp(a)-targeted RNA therapy will be excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, olpasiran could substantially lower Lp(a) and reduce coronary plaque burden, potentially lowering future heart attack risk for people with high Lp(a).

How similar studies have performed: Earlier phase trials of olpasiran and other Lp(a)-lowering RNA therapies have shown large reductions in Lp(a) levels, but proof that lowering Lp(a) translates into less coronary plaque or fewer events remains unproven.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Bridgeport, Connecticut and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cardiovascular Disease, Stable Atherosclerotic Cardiovascular Disease, Elevated Lipoprotein, Coronary Artery Plaque Burden, Olpasiran

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.