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Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients

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 clinical trial is focused on studying the effects of a treatment for Calcific Aortic Valve Stenosis, a condition where the heart's aortic valve becomes narrowed due to calcium buildup, making it harder for the heart to pump blood. The treatment being tested is called pelacarsen, also known by its code name TQJ230. Pelacarsen is an antisense oligonucleotide, which is a type of medication designed to lower levels of a specific protein in the blood called lipoprotein(a). This protein is linked to the progression of the disease.

The purpose of the study is to see if pelacarsen can slow down the worsening of calcific aortic valve stenosis. Participants in the study will receive either pelacarsen or a placebo, which looks like the treatment but does not contain the active medication. The study will last for about 36 months, during which participants will receive regular injections of the treatment or placebo. The effects of the treatment will be monitored through various tests, including echocardiography, which uses sound waves to create images of the heart, and computed tomography (CT), a type of imaging that provides detailed pictures of the heart's structure.

Throughout the study, changes in the heart's function and structure will be assessed to determine if pelacarsen is effective in slowing the disease's progression. Participants will also have their lipoprotein(a) levels checked, and any side effects or health changes will be closely monitored to ensure safety. The study aims to provide valuable information on whether pelacarsen can be a beneficial treatment for people with calcific aortic valve stenosis.

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

    Randomization

    Upon joining the study, participants are randomly assigned to receive either the medication pelacarsen (TQJ230) or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  2. Step 2

    Medication administration

    Participants receive the assigned treatment through subcutaneous injection. The medication is provided in a pre-filled syringe with a needle safety device. The dosage is 80 mg/0.8 mL for those receiving pelacarsen.

  3. Step 3

    Treatment duration

    The treatment is administered regularly over a period of 36 months. The exact frequency of administration is determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular assessments to monitor the progression of calcific aortic valve stenosis. This includes measuring changes in peak aortic jet velocity and aortic valve calcium score using echocardiography and computed tomography, respectively.

  5. Step 5

    Safety evaluations

    Safety is closely monitored by collecting data on any adverse events, serious adverse events, and changes in safety laboratory parameters and vital signs from the start to the end of the study.

  6. Step 6

    Study completion

    The study concludes after 36 months of treatment. Final assessments are conducted to evaluate the overall impact of the treatment on the progression of the condition.

Who can join the trial?

4 criteria

  • Participants must be **male or female** and between **50 to 79 years old**.
  • Participants need to have a **Lipoprotein(a) level** of **175 nmol/L or higher**. Lipoprotein(a) is a type of fat in the blood.
  • Participants should have **mild or moderate calcific aortic valve stenosis**. This means the heart valve has some calcium buildup, causing it to narrow. It is measured by a test showing a **peak aortic jet velocity** between **2.5 and 3.5 meters per second**.
  • At the time of joining the study, participants must be receiving the best possible treatment for any existing **cardiovascular risk factors**. This includes managing things like **LDL cholesterol**, **diabetes**, and **high blood pressure** according to local medical guidelines.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication or its ingredients cannot participate.
  • Individuals with other serious heart conditions, apart from **calcific aortic valve stenosis**, are excluded.
  • Patients who have had a heart attack or stroke in the past six months are not eligible.
  • People with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication, cannot join the study.
  • Individuals with severe kidney disease, which affects how well the kidneys work, are excluded.
  • Patients with liver disease that affects liver function are not eligible.
  • Women who are pregnant or breastfeeding cannot participate in the trial.
  • Individuals who are currently participating in another clinical trial are excluded.
  • Patients who have a history of drug or alcohol abuse in the past year are not eligible.
  • People with any condition that the study doctors believe would make it unsafe for them to participate are excluded.
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Investigated drugs

Pelacarsen (TQJ230) is a medication being studied for its ability to lower lipoprotein(a) levels in the blood. The trial aims to see if reducing lipoprotein(a) can slow down the progression of calcific aortic valve stenosis, a condition where the heart valve becomes narrowed due to calcium buildup. The effectiveness of pelacarsen is being measured by changes in heart valve function and calcium deposits over a period of 36 months.

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 effectiveness in treating calcific aortic valve stenosis, a condition where the heart's aortic valve becomes narrowed due to calcium buildup. The main therapeutic indication for pelacarsen is to slow the progression of this condition. At the molecular level, pelacarsen works by lowering levels of lipoprotein(a), a type of cholesterol that can contribute to heart disease. It is classified as a lipid-lowering agent.

Investigated diseases

Calcific Aortic Valve Stenosis – This disease involves the narrowing of the aortic valve in the heart due to calcium buildup on the valve leaflets. Over time, the valve becomes stiff and less able to open fully, which restricts blood flow from the heart into the aorta and onward to the rest of the body. As the condition progresses, the heart must work harder to pump blood through the narrowed valve, which can lead to symptoms such as chest pain, fatigue, and shortness of breath. The disease typically develops slowly over many years and is more common in older adults. As the stenosis worsens, it can significantly impact heart function and overall circulation. Regular monitoring and evaluation are important to assess the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502135-19-00Protocol codeCTQJ230A12203Estimated enrolment507 patientsSponsorNovartis Pharma AG

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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).