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A Study of Olpasiran for Patients With Stable Heart and Blood Vessel Disease and High Lipoprotein(a) to Measure Changes in Artery Plaque Using Heart Scans

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What is this trial about?

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

This study involves people with cardiovascular disease who have a buildup of fatty deposits called plaque in the arteries of the heart and high levels of a substance in the blood called lipoprotein(a). The treatment being tested is olpasiran, which is also known by the code name AMG 890, or placebo. Olpasiran is a type of medicine designed to lower lipoprotein(a) levels in the blood. High levels of lipoprotein(a) are linked to an increased risk of heart problems because they can contribute to the buildup of plaque in the arteries.

The purpose of this study is to find out if olpasiran can reduce the amount of a specific type of plaque in the heart arteries called non-calcified plaque, which is softer plaque that has not yet hardened with calcium deposits. The study will also look at whether the treatment is safe and well tolerated by participants. The amount of plaque will be measured using a special imaging test called coronary computed tomography angiography, which creates detailed pictures of the heart arteries.

During the study, participants will receive either olpasiran or placebo through an injection under the skin using a pre-filled syringe. The study will last for approximately 72 weeks, during which time imaging scans will be performed to compare the amount of plaque in the arteries at the beginning and end of the treatment period. The study will also measure changes in other types of plaque, including low attenuation plaque, which is a type of softer plaque, total plaque volume, and calcified plaque, which is hardened plaque containing calcium deposits.

The research process

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

Step 1
Initial imaging scan
At the beginning of the trial, you will undergo a coronary computed tomography angiography scan. This is a specialized imaging test that takes detailed pictures of the blood vessels in your heart.
This scan will serve as your baseline measurement, which means it will be used as a starting point to compare changes later in the study.
The scan must meet specific quality standards as determined by a central imaging laboratory.
Step 2
Random assignment to treatment group
You will be randomly assigned to receive either olpasiran or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.
Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.
The assignment is random, similar to flipping a coin, to ensure fair comparison between the two groups.
Step 3
Treatment period with injections
You will receive injections of either olpasiran or placebo under your skin. This type of injection is called subcutaneous administration.
The medication comes in a pre-filled syringe, which is a syringe that already contains the correct dose.
The treatment period will continue for 72 weeks, which is approximately one year and five months.
The specific dosage and frequency of injections will be determined according to the study protocol.
Step 4
Follow-up imaging scan
At week 72, you will undergo another coronary computed tomography angiography scan.
This second scan will be compared to your baseline scan to measure any changes in the plaque in your coronary arteries.
The scan will measure different types of plaque, including non-calcified plaque, which is softer plaque buildup, calcified plaque, which is harder plaque containing calcium, and total plaque volume, which is the overall amount of plaque.
Step 5
Completion of study participation
After the week 72 assessment, your active participation in the treatment phase of the study will be complete.
The entire study is expected to continue until May 2028, though your individual participation timeline may vary.
Throughout the study, various safety assessments and measurements will be conducted to monitor your health and the effects of the treatment.

Who can join the trial?

7 criteria

You must be between 35 and 80 years of age
You must have a blood level of Lp(a), which is a type of cholesterol particle, of 200 nmol/L or higher at the screening visit
You must have a history of atherosclerotic cardiovascular disease, which means you have had disease caused by buildup of fatty deposits in your blood vessels
Your history of atherosclerotic cardiovascular disease must include either a myocardial infarction, which is a heart attack caused by a blockage in the blood vessels supplying your heart, or a coronary revascularization, which is a procedure to restore blood flow to your heart
If you had a coronary revascularization, it must have been done by percutaneous coronary intervention, which is a procedure where a thin tube is inserted into your blood vessels to open blocked arteries
You must have a screening imaging scan of your heart blood vessels called a Coronary Computed Tomography Angiography, which is a special type of X-ray scan that creates detailed pictures of the blood vessels in your heart
Your imaging scan must meet specific quality standards as reviewed by the imaging laboratory

Who cannot join the trial?

3 criteria

The study does not provide specific exclusion criteria in the available information
Please note that participation in this clinical trial requires meeting certain health and medical requirements that will be discussed during the screening process
Your doctor will review your complete medical history to determine if this study is appropriate for you

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
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Amsterdam, The Netherlands
Azienda Ospedaliera Ordine Mauriziano Di Torino
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Turin, Italy
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands

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Investigated drugs

Olpasiran
is an investigational medication being studied to see if it can reduce plaque buildup in the arteries of the heart. This medication works by lowering levels of lipoprotein(a), a type of cholesterol in the blood that can contribute to heart disease. In this study, olpasiran is being tested to see if it can help reduce the amount of plaque in the coronary arteries of people who have stable heart disease and high levels of lipoprotein(a).
Placebo
is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against olpasiran to help determine if the real medication is actually working.

What is already known about the treatment

Olpasiran – Olpasiran is an investigational medication currently being studied in clinical trials for the treatment of cardiovascular disease, specifically in patients with stable atherosclerotic cardiovascular disease and elevated lipoprotein(a) levels. This drug works at the molecular level by using a technology called small interfering RNA (siRNA) to reduce the production of lipoprotein(a), a type of cholesterol particle that contributes to the buildup of plaque in the arteries. The medication is being tested to see if it can reduce non-calcified plaque volume in the coronary arteries, which are the blood vessels that supply the heart, and is administered by injection under the skin.

Investigated diseases

Cardiovascular Disease – Cardiovascular disease refers to a group of conditions affecting the heart and blood vessels. It often involves the buildup of fatty deposits called plaque inside the arteries, which can narrow or block them over time. This process, known as atherosclerosis, develops gradually as cholesterol and other substances accumulate on the artery walls. As plaque increases, it reduces blood flow to the heart and other organs. The plaque can be soft and non-calcified in earlier stages, or it may become hardened with calcium deposits as the disease progresses. Over time, these changes in the arteries can lead to various complications affecting the cardiovascular system.