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Study of Olpasiran to prevent first major cardiovascular events in people with high levels of lipoprotein(a)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Cardiovascular Disease who have elevated levels of lipoprotein(a), a substance in the blood that can increase the risk of heart problems. The research examines a medication called olpasiran to determine if it can help prevent first-time major heart events in people who have never experienced them before.

The study tests whether olpasiran is more effective than a placebo in reducing the risk of serious heart-related events. These events include coronary heart disease death, myocardial infarction (heart attack), and emergency procedures to restore blood flow to the heart. The medication is being studied specifically in people who have high levels of lipoprotein(a) in their blood and are considered at risk for heart problems.

During the study, participants will receive either olpasiran or a placebo while continuing their usual heart medications. The study will track any heart-related events that occur and measure how the treatment affects the amount of lipoprotein(a) in the blood. This research is part of a larger program called OCEAN(a)-PreEvent, which aims to better understand how to prevent first-time heart problems in people with high lipoprotein(a) levels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your lipoprotein(a) levels will be measured through a blood test at a central laboratory

    The test will confirm if your levels are ≥ 200 nmol/L, which is required for participation

    Your current heart health and risk factors for heart disease will be evaluated

  2. Step 2

    Random group assignment

    You will be randomly assigned to receive either olpasiran (the study medication) or a placebo (inactive substance)

    Neither you nor your doctor will know which treatment you are receiving during the study

  3. Step 3

    Treatment period

    The study will continue until 2031

    You will maintain your current heart medications throughout the study

    Your lipoprotein(a) levels will be measured regularly, including a specific check at week 48

    Regular health assessments will monitor for any heart-related events

  4. Step 4

    Health monitoring

    Your heart health will be closely monitored for events such as:

    - Heart attacks

    - Need for urgent heart procedures

    - Stroke

    - Any heart-related complications

  5. Step 5

    Study completion

    The study will end in February 2031

    Final health assessments will be conducted

    Your doctor will discuss follow-up care options with you

Who can join the trial?

7 criteria

  • Must be able to provide written informed consent (agreement to participate) before any study procedures begin
  • Must be 50 years or older at the time of signing the screening consent form
  • Must have a lipoprotein(a) level of 200 nmol/L or higher (a type of blood fat that will be measured during screening)
  • Must be on stable lipid-lowering therapy (medications that help control blood fats) for at least 4 weeks before screening
  • Must meet at least one of these conditions:
    • Have multiple risk factors for heart and blood vessel disease
    • OR have a history of atherosclerosis (buildup of plaque in arteries)
    • Both men and women can participate in the study

Who cannot join the trial?

12 criteria

  • History of heart attack (myocardial infarction) or coronary revascularization (heart procedure to restore blood flow)
  • Currently taking medications that significantly affect blood lipids (fat-like substances in blood)
  • Severe kidney disease or currently on dialysis (blood filtering treatment)
  • Uncontrolled high blood pressure (blood pressure consistently above 160/100)
  • History of bleeding disorders or significant bleeding events in the past 6 months
  • Active liver disease or abnormal liver function tests
  • Current participation in other clinical trials or within past 30 days
  • Known allergic reactions to similar medications
  • Pregnant women or those planning pregnancy during the study period
  • History of substance abuse within the past year
  • Any condition that, in the opinion of study doctors, would make participation unsafe
  • Unable to provide informed consent or follow study procedures
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Investigated drugs

Olpasiran is an investigational medication designed to reduce levels of lipoprotein(a), also known as Lp(a), in the blood. This medication is being studied to prevent first major cardiovascular events in people who have high levels of lipoprotein(a). Olpasiran works by targeting and reducing the production of lipoprotein(a), which is a type of fat-protein particle that can contribute to heart disease when present in elevated amounts. The trial also includes a placebo, which is not an active medication but is used as a comparison to evaluate the effectiveness of olpasiran.

What is already known about the treatment

Olpasiran - A novel investigational medication administered via subcutaneous injection that targets elevated lipoprotein(a) levels in patients at risk for cardiovascular events. This small interfering RNA (siRNA) therapeutic works by reducing the production of lipoprotein(a) in the liver by blocking specific messenger RNA, effectively lowering blood levels of this risk factor. Currently undergoing clinical trials for the prevention of major cardiovascular events such as coronary heart disease death, heart attacks, and urgent coronary procedures in patients with elevated lipoprotein(a) levels. The medication belongs to the class of RNA interference therapeutics and represents a targeted approach to cardiovascular disease prevention.

Investigated diseases

  • Coronary Heart Disease

    A condition where the heart's blood vessels become narrowed or blocked by fatty deposits called plaques. This process develops gradually over many years as cholesterol and other substances build up on the artery walls. The reduced blood flow can cause chest pain and shortness of breath during physical activity.

  • Myocardial Infarction

    Also known as a heart attack, it occurs when blood flow to a part of the heart muscle becomes blocked. The blockage is usually caused by a buildup of fatty deposits in the coronary arteries that suddenly ruptures and forms a clot. This leads to damage or death of the affected heart muscle tissue.

  • Ischemic Stroke

    A condition that occurs when blood flow to the brain is blocked by a clot in a blood vessel. The blockage prevents brain cells from receiving oxygen and nutrients they need. This type of stroke develops suddenly and affects specific areas of the brain depending on which blood vessel is blocked.

  • Cardiovascular Disease

    A broad term for conditions affecting the heart and blood vessels throughout the body. It develops when arteries become stiff and narrow, making it harder for blood to flow freely. The condition typically progresses slowly over many years and can affect different parts of the circulatory system.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520554-11-00Protocol code20230222Estimated enrolment11 000 patientsSponsorAmgen Inc.

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