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Study on Long-Term Safety of Pelacarsen for Patients with Cardiovascular Disease Who Completed the Frontiers Apheresis Study

Verified siteInvestigationalNo placebo
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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 long-term safety and tolerability of a treatment called pelacarsen, also known by its code name TQJ230. The study is specifically for patients with cardiovascular disease who have previously participated in a related study. Cardiovascular disease refers to conditions affecting the heart and blood vessels, which can lead to serious health issues like heart attacks or strokes. The treatment involves a solution for injection that is administered using a pre-filled syringe.

The purpose of this study is to evaluate how well patients tolerate the treatment over an extended period. Participants will receive the treatment through injections under the skin, known as subcutaneous use. The study will monitor any adverse effects or serious adverse events, as well as changes in laboratory evaluations and vital signs. The study will also track the number of lipoprotein apheresis sessions, a procedure that removes certain fats from the blood, performed each year for up to five years.

Throughout the study, the levels of a specific type of fat in the blood, known as Lp(a), will be measured at various intervals to see how they change compared to the start of the previous study. This will help researchers understand the long-term impact of pelacarsen on cardiovascular health. Participants in this study have already completed a prior study and are considered safe to continue by their healthcare provider. The study aims to provide valuable information on the safety of pelacarsen for individuals with cardiovascular disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form. This document confirms understanding and agreement to participate in the study.

    Eligibility requires successful completion of the previous study, known as the parent study, and a determination by the investigator that participation is safe.

  2. Step 2

    Medication administration

    The medication used in this study is called pelacarsen, also known as TQJ230.

    It is administered as a solution for injection using a pre-filled syringe.

    The injection is given under the skin, a method known as subcutaneous use.

  3. Step 3

    Monitoring and assessments

    Regular monitoring includes checking for any adverse events or serious adverse events, conducting laboratory evaluations, and measuring vital signs.

    The duration of drug exposure is also recorded to ensure safety and tolerability.

  4. Step 4

    Lipoprotein apheresis sessions

    The number of lipoprotein apheresis sessions is tracked yearly for up to five years.

    Lipoprotein apheresis is a procedure that removes certain fats from the blood.

  5. Step 5

    Evaluation of lipoprotein levels

    The study measures changes in lipoprotein levels, specifically Lp(a), at various intervals: month 1, month 3, month 6, month 9, month 12, and then every six months.

    These measurements are compared to the baseline levels recorded in the parent study.

  6. Step 6

    Study duration

    The study is expected to continue until September 2, 2028.

    Participants will be involved in the study for the duration necessary to complete all required assessments and monitoring.

Who can join the trial?

5 criteria

  • The participant must provide a signed informed consent before joining the study. This means they agree to take part after understanding what the study involves.
  • The participant must have successfully completed the previous study, known as the "parent study," and be considered safe to join this study by the doctor's judgment. If the participant had to stop the previous study early for medical or safety reasons before week 52, they are not considered to have completed it successfully.
  • Both men and women can participate in the study.
  • The study includes people from certain age groups, specifically adults and older adults.
  • The study may include individuals who are considered part of a vulnerable population, meaning they might need extra care or protection.

Who cannot join the trial?

1 criterion

  • Patients who are currently undergoing apheresis cannot participate. Apheresis is a medical procedure where blood is taken from the body, a part of it is removed or treated, and then the rest is returned to the body.
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Investigated drugs

Pelacarsen (TQJ230) is a medication being studied for its long-term safety and tolerability in patients with cardiovascular disease. It is designed to help manage elevated levels of lipoprotein(a), which is a type of fat in the blood that can increase the risk of heart disease. This study is for patients who have already completed a previous study involving this medication.

What is already known about the treatment

Pelacarsen – Pelacarsen is administered as an injection, typically under the skin. It is currently being studied in clinical trials to assess its long-term safety and tolerability in patients with cardiovascular disease. The main therapeutic indication for pelacarsen is to manage elevated lipoprotein(a) levels, which are associated with cardiovascular conditions. 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

Cardiovascular Disease – Cardiovascular disease refers to a group of disorders affecting the heart and blood vessels. It often involves narrowed or blocked blood vessels, which can lead to chest pain, heart attacks, or strokes. Over time, these conditions can cause the heart to weaken or fail. The disease progresses as plaque builds up in the arteries, leading to reduced blood flow. This can result in symptoms like shortness of breath, fatigue, and irregular heartbeats. Lifestyle factors such as diet, exercise, and smoking can influence the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503611-16-00Protocol codeCTQJ230A12302E1Estimated enrolment60 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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