Cardiovascular DiseasePhase 3OCEAN(a)-CCTANCT07293260
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial
A Phase 3 study testing Olpasiran in people with Cardiovascular Disease, run by Amgen at 40 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Olpasiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 40 sitesin 11 countries
- Study dates
- 23 Mar 2026to 15 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Severe heart failure.
- Current, recent, or planned lipoprotein apheresis.
- Previously received ribonucleic acid therapy specifically targeting Lp(a).
Trial locations and contacts
40 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 11 countries
China8 sites, 8 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
- Recruiting
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
United States6 sites, 6 recruiting
- Recruiting
Flourish Bowie
Bowie, Maryland, 20715
- Recruiting
Bridgeport Hospital
Bridgeport, Connecticut, 06610
- Recruiting
Vital Heart and Vein
Humble, Texas, 77338
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
- Recruiting
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
- Recruiting
Montefiore Medical Center - Bronx
Philadelphia, Pennsylvania, 19141
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, 06000
- Recruiting
Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque
Pessac, 33604
- Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059
- Recruiting
Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
Tours, 37044
Germany4 sites, 4 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
- Recruiting
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590
- Recruiting
Klinikum rechts der Isar der TUM
München, 80636
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, 44124
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, 20138
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, 20097
- Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28023
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, Galicia, 36312
Australia3 sites, 3 recruiting
- Recruiting
Advara HeartCare Wesley
Auchenflower, Queensland, 4066
- Recruiting
Advara HeartCare Leabrook
Leabrook, South Australia, 5068
- Recruiting
University of The Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, 4556
Japan3 sites, 3 recruiting
- Recruiting
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898
- Recruiting
Osaka Keisatsu Hospital
Osaka, Osaka, 543-0042
- Recruiting
Tomakomai City Hospital
Tomakomai-shi, Hokkaido, 053-8567
Denmark2 sites, 2 recruiting
- Recruiting
Regionshospitalet Gødstrup
Herning, 7400
- Recruiting
Regionshospitalet Viborg
Viborg, 8800
Canada1 site, 1 recruiting
- Recruiting
North York Diagnostic and Cardiac Centre
Vaughan, Ontario, L6A 4N9
Netherlands1 site, 1 recruiting
- Recruiting
Tergooiziekenhuizen, locatie Hilversum
Hilversum, 1201 DA
About this study
Official 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)
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
- Being tested
- Olpasiran, Placebo
- Keywords
- Stable Atherosclerotic Cardiovascular Disease, Elevated Lipoprotein(a), Coronary Artery Plaque Burden, Olpasiran
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlpasiranDrug
Also called AMG 890
Olpasiran will be administered SC.
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Olpasiran | Experimental | Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W). Receives: Drug: Olpasiran |
| Placebo | Placebo comparator | Participants will receive placebo SC Q12W. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NCP Volume from Baseline to Week 72
Measured: Baseline to Week 72
Secondary outcomes (4)
Change in Low Attenuation Plaque Volume from Baseline to Week 72
Measured: Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72
Measured: Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72
Measured: Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Week 74
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start23 Mar 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293260
- Sponsor's protocol ID
- 20230191
- Acronym
- OCEAN(a)-CCTA
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07293260
- Acronym / sponsor ID
- OCEAN(a)-CCTA / 20230191
- Conditions
- Cardiovascular Disease
- Keywords
- Stable Atherosclerotic Cardiovascular Disease, Elevated Lipoprotein(a), Coronary Artery Plaque Burden, Olpasiran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olpasiran | Experimental | Drug: OlpasiranParticipants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC Q12W. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlpasiranAlso: AMG 890Olpasiran will be administered SC. | Drug | Olpasiran |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
Primary outcome
Change in NCP Volume from Baseline to Week 72
Time frame: Baseline to Week 72
4 secondary outcomes
Change in Low Attenuation Plaque Volume from Baseline to Week 72
Time frame: Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72
Time frame: Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72
Time frame: Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 74
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
40 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olpasiran in people with Cardiovascular Disease, run by Amgen at 40 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in China, United States, France, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NCP Volume from Baseline to Week 72 (time frame: Baseline to Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.