OCEAN(a)-PreEvent - Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction to Prevent first major cardiovascular Events

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-09-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc.

External identifiers

EU CT number

2025-520554-11-00

WHO UTN

U1111-1285-8310

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a])

Secondary objectives 4

1. To evaluate the effect of olpasiran, compared to placebo, in participants at risk for a first major cardiovascular event with elevated Lp(a) on the risk for: - cardiovascular death, myocardial infarction, or ischemic stroke - cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke
2. To evaluate the effect of olpasiran, compared to placebo, in participants at risk for a first major cardiovascular event with elevated Lp(a) on change from baseline Lp(a) levels
3. To evaluate the effect of olpasiran, compared to placebo, in participants at risk for a first major cardiovascular event with elevated Lp(a) on the risk for: - myocardial infarction - CHD death or myocardial infarction - urgent coronary revascularization - coronary revascularization - CHD death - cardiovascular death - death by any cause - ischemic stroke
4. To evaluate pharmacokinetics (PK) of olpasiran in participants at risk for a first major cardiovascular event with elevated Lp(a)

Conditions and MedDRA coding

Cardiovascular Disease

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002910-PIP01-20

Plan to share 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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant has provided written informed consent before initiation of any studyspecific activities/procedures.
2. Age ≥ 50 years at the time of signing of the Lp(a) screening ICF.
3. Lp(a) ≥ 200 nmol/L during Lp(a) screening by a central laboratory using an investigational IVD test. - At least 4 weeks of stable and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines or according to investigator’s judgment before Lp(a) screening.
4. Participants meeting at least one of the following categories (A or B): A. Multiple risk factors for atherosclerotic disease AND/OR B. History of atherosclerosis

Exclusion criteria 5

1. Prior acute atherothrombotic qualifying event at any time, defined as prior myocardial infarction, prior stroke, prior transient ischemic attack, or prior acute limb ischemia.
2. Prior arterial revascularization at any time suspected to be associated with atherosclerosis.
3. History of major bleeding disorder (eg, hemophilia, von Willebrand disease, clotting factor deficiencies, etc).
4. Planned arterial revascularization (percutaneous or surgical).
5. Fasting triglycerides > 400 mg/dL (4.52 mmol/L) during screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

Secondary endpoints 3

1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
3. Percent change from baseline to week 48 Lp(a) levels

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 11

Locations

17 EU/EEA countries · 352 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 195 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications