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NCT Number: NCT07293260

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

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).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advara HeartCare Wesley, Auchenflower, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Olpasiran

Drug

Olpasiran will be administered SC.

Other names: AMG 890

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

  1. Change in NCP Volume from Baseline to Week 72

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change in Low Attenuation Plaque Volume from Baseline to Week 72

    Time frame: Baseline to Week 72

  2. Change in Total Plaque Volume from Baseline to Week 72

    Time frame: Baseline to Week 72

  3. Change in Calcified Plaque Volume from Baseline to Week 72

    Time frame: Baseline to Week 72

  4. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Week 74

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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)

Acronym: OCEAN(a)-CCTA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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