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A study to evaluate the effect of olpasiran on major cardiovascular events in patients with atherosclerotic cardiovascular disease and high levels of lipoprotein(a)

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study investigates the effects of olpasiran in individuals diagnosed with atherosclerotic cardiovascular disease, a condition where plaque builds up in the arteries, and elevated lipoprotein (a), which is a specific type of fatty protein found in the blood. The purpose of the study is to compare the impact of the study drug against a placebo on the risk of major heart-related issues. These issues include coronary heart disease death, myocardial infarction, or the need for urgent coronary revascularization, which is a procedure used to restore blood flow to the heart.

Participants will be assigned to receive either olpasiran or a placebo through a subcutaneous injection, which means the medication is delivered into the fatty tissue just under the skin. During the study, researchers will monitor for various health events such as ischemic stroke, which is a blockage of blood flow to the brain, and cardiovascular death. The study will also track changes in the levels of lipoprotein (a) in the blood over time to see how the treatment affects this substance.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study participation</b>

    You will receive either the test medication, known as olpasiran, or a placebo, which is an inactive substance that looks like the medication but contains no active ingredients.

    The olpasiran is administered as a subcutaneous injection, which means it is injected just under the skin, using a pre-filled syringe containing a solution.

  2. Step 2

    <b>monitoring and evaluation</b>

    The study focuses on tracking health events related to atherosclerotic cardiovascular disease (a condition where blood vessels harden and narrow) and elevated lipoprotein (a) (a specific type of protein in the blood that can increase heart risks).

    The duration of the study involves monitoring for specific health outcomes, such as changes in lipoprotein (a) levels, which are measured up to week 48.

Who can join the trial?

6 criteria

  • You must provide informed consent, which means you agree to participate in the study after being given all the necessary information.
  • You must be between 18 and 85 years old at the time you sign the consent form.
  • Your blood test must show high levels of Lp(a) (lipoprotein a), which is a specific type of fatty substance in your blood, with a level of 200 nmol/L or higher.
  • You must have been taking a stable and effective dose of lipid-lowering therapy (medicine used to lower cholesterol or fats in the blood) for at least 2 weeks before your testing.
  • You must have a history of atherosclerotic cardiovascular disease (ASCVD), which is a condition where the arteries that carry blood to the heart become narrowed or blocked by buildup.
  • Your history must include either a myocardial infarction (commonly known as a heart attack) or coronary revascularization (a procedure used to improve blood flow to the heart, such as percutaneous coronary intervention, which is a way to open blocked heart arteries using a small tube and a balloon or stent).

Who cannot join the trial?

6 criteria

  • You have severe renal dysfunction, which means your kidneys are not working well enough. This is measured by a test called eGFR, which checks how well your kidneys filter waste from your blood.
  • You have high levels of certain liver enzymes, specifically AST or ALT, or high levels of total bilirubin. These are tests used to check for liver health or damage.
  • You have a history of hemorrhagic stroke, which is a type of stroke caused by bleeding inside the brain.
  • You have a history of a major bleeding disorder, such as hemophilia or von Willebrand disease, which are conditions that prevent your blood from clotting properly.
  • You have had a major cardiovascular event within the last 4 weeks. This includes things like a myocardial infarction (heart attack), unstable angina (chest pain caused by reduced blood flow), PCI (a procedure to open clogged heart arteries), coronary artery bypass graft (surgery to improve blood flow to the heart), or a stroke.
  • You have a planned cardiac surgery or arterial revascularization, which are medical procedures intended to improve blood flow through your arteries or heart.
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Investigated drugs

Olpasiran is an injectable medication used to help lower the levels of a specific type of fat in the blood called lipoprotein (a). In this study, it is being tested to see if it can reduce the risk of serious heart problems, such as heart attacks or the need for urgent heart procedures, in people who already have heart disease.

What is already known about the treatment

Olpasiran - This medication is given as an injection through a small needle under the skin using a pre-filled syringe. Currently being studied in clinical trials, it is being investigated as a way to treat heart disease and high levels of a specific type of fat in the blood called lipoprotein (a). It works by using a specialized genetic technique to block the production of this harmful protein at the source within the body. It belongs to a class of drugs known as RNA interference therapies that target the underlying cause of high cholesterol levels.

Investigated diseases

Atherosclerotic cardiovascular disease - This condition occurs when fatty deposits, called plaques, build up inside the arteries. These plaques can cause the arteries to narrow and harden over time. As the buildup increases, it restricts the flow of oxygen-rich blood to various parts of the body. This process can lead to blockages in the vessels that supply the heart or the brain. Eventually, the reduced blood flow may cause significant damage to these organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501608-85-00Protocol code20180244Estimated enrolment6 330 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).