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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Bridgeport Hospital
  Bridgeport, Connecticut, United States Recruiting
• Jacksonville Center for Clinical Research
  Jacksonville, Florida, United States Recruiting
• Midwest Heart and Vascular Specialists
  Overland Park, Kansas, United States Recruiting
• Flourish Bowie
  Bowie, Maryland, United States Recruiting
• Montefiore Medical Center - Bronx
  Philadelphia, Pennsylvania, United States Recruiting
• Vital Heart and Vein
  Humble, Texas, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.