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Long-term safety study of pelacarsen in patients with atherosclerotic cardiovascular disease who completed the Lp(a)HORIZON trial

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 focuses on studying a medication called pelacarsen (also known as TQJ230) in people who have atherosclerotic cardiovascular disease. This is a condition where arteries become hardened and narrowed due to the buildup of fatty deposits on their walls. The study specifically looks at patients who have high levels of a substance called Lp(a) in their blood, which is associated with increased heart disease risk.

The purpose of this research is to evaluate how safe the medication is and how well patients tolerate it when used for a longer period. The medication is given as a subcutaneous injection (under the skin) using a pre-filled syringe. This is an open-label extension study, which means all participants will receive the actual medication, and it continues treatment for patients who completed an earlier study called Lp(a)HORIZON.

During the study, participants will receive regular doses of pelacarsen for up to 36 months. The maximum daily dose is 80 milligrams. The study will monitor participants' health through regular check-ups and blood tests to ensure their safety while taking the medication. Researchers will track various health measurements and any side effects that may occur during the treatment period.

The research process

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

  1. Step 1

    Initial visit

    You will receive information about the open-label extension trial that evaluates the long-term safety of pelacarsen (TQJ230) medication

    The trial is designed for patients who have completed the previous Lp(a)HORIZON study

    You will need to provide informed consent before any study procedures begin

  2. Step 2

    Medication administration

    You will receive pelacarsen (TQJ230) as a solution for injection

    The medication will be administered through subcutaneous injection (under the skin) using a pre-filled syringe

    The treatment will continue throughout the study period until 2029

  3. Step 3

    Safety monitoring

    Regular check-ups will monitor your health status and any potential side effects

    Medical staff will track any adverse events (unwanted effects) that may occur during treatment

    Laboratory tests will be performed to monitor your health indicators

    Your vital signs will be regularly checked

  4. Step 4

    Health measurements

    Your Lp(a) levels (a type of cholesterol) will be measured throughout the study

    The medical team will monitor your cardiovascular health

    Changes in your health status will be compared to your initial condition from both the previous study and this extension trial

  5. Step 5

    Study completion

    The study is expected to continue until March 31, 2029

    Final health assessments will be conducted to evaluate the overall effects of the treatment

Who can join the trial?

6 criteria

  • Must be aged between 18 and 85 years old
  • Must provide informed consent (written agreement to participate) before any study procedures begin
  • Must have completed the previous Lp(a)HORIZON study while still taking the study medication
  • Must have established cardiovascular disease (conditions affecting the heart and blood vessels)
  • Must have elevated levels of Lp(a) (a type of protein in the blood that can increase risk of heart disease)
  • Can be either male or female

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions or anaphylaxis to any oligonucleotide (type of medication) or components of pelacarsen
  • Presence of active, chronic, or recurring inflammatory conditions (diseases causing inflammation in the body)
  • Significant kidney problems with estimated glomerular filtration rate (kidney function test) below 30 mL/min/1.73m²
  • Uncontrolled high blood pressure (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
  • History of major bleeding within the past 12 months
  • Active liver disease or significant liver function abnormalities
  • Currently pregnant or breastfeeding women
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to comply with study procedures or follow-up visits
  • Participation in another clinical trial within 30 days before this study
  • Current drug or alcohol abuse that could interfere with study participation
  • Life expectancy less than the duration of the study due to other medical conditions
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Investigated drugs

Pelacarsen (TQJ230) is a medication being studied for people with elevated levels of Lp(a) and established cardiovascular disease. This medication is designed to help reduce Lp(a) levels in the blood. Lp(a) is a type of lipoprotein that can increase the risk of heart disease when present in high amounts. The medication is being evaluated for its long-term safety and how well patients can tolerate it over an extended period.

What is already known about the treatment

Pelacarsen (TQJ230) - An investigational medication administered through injection that is being studied for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients with elevated lipoprotein(a) levels. This drug belongs to the class of antisense oligonucleotides and works by reducing the production of lipoprotein(a) in the liver by targeting specific messenger RNA. Currently undergoing clinical trials to evaluate its long-term safety and effectiveness, pelacarsen represents a novel approach to managing cardiovascular risk in patients who have completed the Lp(a)HORIZON study and have established cardiovascular disease.

Investigated diseases

Atherosclerotic Cardiovascular Disease (ASCVD) - A condition where fatty deposits (plaque) build up inside the arteries, causing them to narrow and harden over time. The plaque consists mainly of fat, cholesterol, and other substances that accumulate on the inner walls of blood vessels. This progressive disease develops slowly over many years, often starting in early adulthood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The condition can affect arteries throughout the body, particularly those supplying blood to the heart, brain, and limbs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519870-38-00Protocol codeCTQJ230A12301E1Estimated enrolment5 849 patientsSponsorNovartis Pharma AG

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