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

NCT ID: NCT07293260

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-21

Study Completion Date

2028-06-02

Brief Summary

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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).

Detailed Description

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Conditions

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Cardiovascular Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Olpasiran

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

Group Type EXPERIMENTAL

Olpasiran

Intervention Type DRUG

Olpasiran will be administered SC.

Placebo

Participants will receive placebo SC Q12W.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered SC.

Interventions

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Olpasiran

Olpasiran will be administered SC.

Intervention Type DRUG

Placebo

Placebo will be administered SC.

Intervention Type DRUG

Other Intervention Names

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AMG 890

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Central Contacts

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Amgen Call Center

Role: CONTACT

Phone: 866-572-6436

Email: [email protected]

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20230191

Identifier Type: -

Identifier Source: org_study_id