Olpasiran for Cardiovascular Disease

Recruiting at 145 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Prior atherothrombotic event, Revascularization, Bleeding disorder

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 6.2 years

11000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective is 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\[a\]).

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older who are at risk of a first major heart event and have high levels of lipoprotein(a), a type of fat in the blood. They should also have multiple risk factors for heart disease or signs of atherosclerosis but no history of acute heart events, bleeding disorders, or past/planned artery-clearing procedures.

Inclusion Criteria

I am 50 years old or older.

Lp(a)≥ 200 nmol/L during screening

I have risk factors for heart disease or signs of atherosclerosis.

Exclusion Criteria

I have had a heart attack, stroke, or similar event before.

I have a history of a major bleeding disorder.

I have had or am planning to have surgery to restore blood flow in my arteries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous olpasiran or placebo to evaluate the effect on cardiovascular events

Up to approximately 6.2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olpasiran

Trial Overview The study aims to see if Olpasiran can reduce the chance of death from coronary heart disease, heart attacks, or urgent need for artery-clearing procedures compared to a placebo in people with elevated lipoprotein(a) who haven't had major cardiovascular events before.

How Is the Trial Designed?

Group I: Olpasiran Experimental Treatment 1 Intervention

Participants will receive subcutaneous (SC) olpasiran.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive SC placebo.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London