Recruiting

Olpasiran for Preventing Cardiovascular Events in Elevated Lipoprotein(a)

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What is being tested

Olpasiran

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases+8

+ Coronary Disease

+ Heart Diseases

From 50 to 105 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out if a drug called olpasiran can help prevent serious heart problems in people with high levels of a specific substance in their blood known as lipoprotein(a). People with elevated lipoprotein(a) are more at risk of heart disease, including deaths caused by coronary heart disease, heart attacks, or the need for urgent heart procedures. The goal is to see if olpasiran can lower these risks compared to a placebo, which is a substance with no active drug. Participants in the study will receive either the olpasiran drug or a placebo. The study is conducted in a way that neither the participants nor the researchers know who is receiving the actual drug or the placebo, which helps ensure unbiased results. The researchers will measure the effectiveness by keeping track of occurrences of heart-related events in the participants. The potential benefits include reducing the risk of major cardiovascular events for those with high lipoprotein(a), although like any clinical trial, there could be risks or side effects that will be monitored closely.

Official TitleA Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
NCT07136012
Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

11000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 105 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Criteria

3 inclusion criteria required to participate
Age ≥50 years

Lp(a)≥ 200 nmol/L during screening

Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

3 exclusion criteria prevent from participating
Prior or planned arterial revascularization

History of major bleeding disorder

Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive subcutaneous (SC) olpasiran.

Group II

Placebo
Participants will receive SC placebo.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 215 locations

Recruiting

Chase Medical Research LLC

Waterbury, United StatesOpen Chase Medical Research LLC in Google Maps
Recruiting

Excel Medical Clinical Trials

Boca Raton, United States
Recruiting

Clearwater Cardiovascular Consultants

Clearwater, United States
Recruiting

Proactive Clinical Research

Fort Lauderdale, United States
Recruiting
215 Study Centers