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Study on Reducing Lipoprotein Apheresis with Pelacarsen in Patients with High Lipoprotein(a) and Heart Disease in Germany

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called pelacarsen (also known by its code name TQJ230) in patients with a condition known as hyperlipoproteinemia(a). This condition is characterized by high levels of a type of cholesterol called lipoprotein(a), which can lead to cardiovascular diseases such as heart attacks and strokes. Patients with this condition often undergo a procedure called lipoprotein apheresis, which is a process that removes lipoprotein(a) from the blood. The trial aims to see if pelacarsen can reduce the need for these apheresis sessions.

Participants in the study will receive either pelacarsen or a placebo, which is a substance with no active medication, through an injection. The study will last for 52 weeks, during which the frequency of lipoprotein apheresis sessions will be monitored. The goal is to determine if pelacarsen can decrease the number of apheresis sessions needed by patients, potentially improving their quality of life and reducing the burden of treatment.

The trial is designed to compare the effects of pelacarsen with those of a placebo in a controlled setting. By the end of the study, researchers hope to demonstrate that pelacarsen is more effective than the placebo in reducing the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established cardiovascular disease. This could lead to new treatment options for managing this condition and its associated health risks.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. This includes having undergone lipoprotein apheresis for at least 12 months prior to the study, with a minimum of 35 sessions in the past year.
Lipoprotein(a) levels must be greater than 60 mg/dL, and there must be a history of certain cardiovascular conditions such as myocardial infarction, ischemic stroke, or significant peripheral or coronary artery disease.
Step 2
Randomization and treatment
Participants are randomly assigned to receive either the active medication, pelacarsen (TQJ230), or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
The medication is administered as a solution for injection using a pre-filled syringe with a needle safety device. The route of administration is subcutaneous, meaning it is injected under the skin.
Step 3
Treatment duration
The treatment period lasts for 52 weeks. During this time, the primary goal is to assess the reduction in the rate of lipoprotein apheresis sessions.
Participants continue their regular schedule of weekly lipoprotein apheresis sessions, and the study aims to demonstrate the superiority of pelacarsen in reducing these sessions compared to the placebo.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring and assessments are conducted to evaluate the impact of the treatment. This includes measuring changes in lipoprotein(a) levels and tracking the frequency of apheresis sessions.
Secondary outcomes include the time to avoidance of apheresis sessions and total avoidance from week 12 to week 52, as well as changes in lipoprotein(a) levels from the start of the study to week 52.
Step 5
Completion of the study
The study is expected to conclude by January 29, 2025. At the end of the study, data collected will be analyzed to determine the effectiveness of pelacarsen in reducing the need for lipoprotein apheresis.
Participants will be informed of the study results and any potential implications for their ongoing treatment.

Who can join the trial?

7 criteria

Patients must be currently undergoing **lipoprotein apheresis**. This is a procedure to remove certain fats from the blood. It should be done for isolated **Lp(a)** on a weekly schedule in Germany for at least 12 months before the screening, with at least 35 sessions in the past 52 weeks before joining the study.
Patients must have **Lipoprotein(a)** levels greater than 60 mg/dL at the time of screening. Lipoprotein(a) is a type of fat in the blood.
Patients must have had a **spontaneous prior myocardial infarction (MI)**, which is a heart attack, at least 3 months before the screening visit.
Patients may have had an **ischemic stroke**, which is a type of stroke caused by a blockage in the blood supply to the brain, at least 3 months before the screening visit.
Patients may have **clinically significant symptomatic peripheral artery disease (PAD)**, which affects blood flow to the limbs, or **clinically significant symptomatic coronary artery disease (CAD)**, which affects blood flow to the heart.
Both male and female patients are eligible to participate.
The study includes patients from vulnerable populations, meaning those who may need special protection or consideration.

Who cannot join the trial?

6 criteria

Patients who are currently undergoing **apheresis**. Apheresis is a medical procedure that removes certain components from the blood.
Patients who do not have **hyperlipoproteinemia(a)**. This is a condition where there is a high level of a specific type of fat in the blood.
Patients who do not have **established CVD**. CVD stands for cardiovascular disease, which affects the heart and blood vessels.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are part of a vulnerable population that the study is not designed to include.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
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Mainz, Germany
Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
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Ulm, Germany

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Investigated drugs

Pelacarsen (TQJ230) is a medication being studied for its ability to reduce the frequency of lipoprotein apheresis sessions in patients with high levels of lipoprotein(a) and established cardiovascular disease. The trial aims to demonstrate that treatment with pelacarsen can effectively lower the need for these apheresis sessions over a period of 52 weeks.

Pelacarsen

What is already known about the treatment

Pelacarsen – Pelacarsen is administered via injection and is currently being studied in clinical trials for its potential to reduce the frequency of lipoprotein apheresis sessions in patients with high levels of lipoprotein(a) and established cardiovascular disease. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for pelacarsen is hyperlipoproteinemia(a), a condition characterized by elevated lipoprotein(a) levels, which can contribute to cardiovascular disease. At the molecular level, pelacarsen works by targeting and reducing the production of lipoprotein(a) in the liver. It is classified pharmacologically as an antisense oligonucleotide, which is a type of medication designed to interfere with the production of specific proteins.

Investigated diseases

Hyperlipoproteinemia(a) – This condition is characterized by elevated levels of lipoprotein(a) in the blood, which is a type of lipoprotein that carries cholesterol. It is a genetic disorder that can lead to the buildup of cholesterol in the arteries, increasing the risk of cardiovascular diseases. Over time, the excess lipoprotein(a) can contribute to the formation of plaques in the arteries, leading to atherosclerosis. This process can result in reduced blood flow and potentially cause complications such as heart attacks or strokes. The progression of hyperlipoproteinemia(a) is influenced by genetic factors and can vary in severity among individuals. Regular monitoring and management are essential to control its impact on cardiovascular health.