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

April 15, 2026 updated by: Amgen

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

406

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Advara HeartCare Wesley
      • Sippy Downs, Queensland, Australia, 4556
        • Recruiting
        • University of The Sunshine Coast Clinical Trials, Sippy Downs
    • South Australia
      • Leabrook, South Australia, Australia, 5068
        • Recruiting
        • Advara HeartCare Leabrook
  • Canada
    • Ontario
      • Vaughan, Ontario, Canada, L6A 4N9
        • Recruiting
        • North York Diagnostic and Cardiac Centre
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial Peoples Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
  • Denmark
      • Herning, Denmark, 7400
        • Recruiting
        • Regionshospitalet Gødstrup
      • Viborg, Denmark, 8800
        • Recruiting
        • Regionshospitalet Viborg
  • France
      • Nice, France, 06000
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
      • Pessac, France, 33604
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
      • Tours, France, 37044
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
      • Frankfurt am Main, Germany, 60590
        • Recruiting
        • Universitaetsklinikum Frankfurt
      • München, Germany, 80636
        • Recruiting
        • Klinikum rechts der Isar der TUM
  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
      • Milan, Italy, 20138
        • Recruiting
        • IRCCS Centro Cardiologico Monzino
      • San Donato Milanese, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
      • Torino, Italy, 10128
        • Recruiting
        • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Japan
    • Hokkaido
      • Tomakomai-shi, Hokkaido, Japan, 053-8567
        • Recruiting
        • Tomakomai City Hospital
    • Osaka
      • Osaka, Osaka, Japan, 543-0042
        • Recruiting
        • Osaka Keisatsu Hospital
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi Hospital
  • Netherlands
      • Hilversum, Netherlands, 1201 DA
        • Recruiting
        • Tergooiziekenhuizen, locatie Hilversum
  • Spain
      • Madrid, Spain, 28023
        • Recruiting
        • Hospital Universitario Ramon y Cajal
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
    • Galicia
      • Vigo, Galicia, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Recruiting
        • Bridgeport Hospital
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Specialists
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Bowie
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Montefiore Medical Center - Bronx
    • Texas
      • Humble, Texas, United States, 77338
        • Recruiting
        • Vital Heart and Vein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olpasiran
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Drug: Olpasiran
Olpasiran will be administered SC.
Other Names:
  • AMG 890
Placebo Comparator: Placebo
Participants will receive placebo SC Q12W.
Drug: Placebo
Placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in NCP Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Low Attenuation Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 74
Up to Week 74

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2028

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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