Recruiting
Phase 3

Olpasiran

Sponsor:

Amgen

Code:

NCT07293260

Conditions

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Olpasiran

Placebo

Study Details

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).

Conditions

Cardiovascular Disease

Study ID

NCT07293260

Start date

Mar 23, 2026

Status verified date

Apr, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

406 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Olpasiran

Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).

placebo comparator: Placebo

Participants will receive placebo SC Q12W.

Interventions

Olpasiran

Olpasiran will be administered SC.

Placebo

Placebo will be administered SC.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Bridgeport Hospital

Recruiting

Bridgeport, Connecticut, United States, 06610

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Midwest Heart and Vascular Specialists

Recruiting

Overland Park, Kansas, United States, 66211

Flourish Bowie

Recruiting

Bowie, Maryland, United States, 20715

Montefiore Medical Center - Bronx

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

North York Diagnostic and Cardiac Centre

Recruiting

Vaughan, Ontario, Canada, L6A 4N9

More Information

Sponsor

Amgen

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-04-16.