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Open-label long-term pelacarsen (TQJ230) extension for people with heart disease and high Lp(a)

A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial

Phase 3 Interventional Novartis · NCT07517263

People with established cardiovascular disease and high Lp(a) who finished the parent study will get monthly pelacarsen injections to see if the drug remains safe and tolerable over the long term.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5700 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations492 sites (Andalusia, Alabama and 491 other locations)
Trial IDNCT07517263 on ClinicalTrials.gov

What this trial studies

This open-label extension enrolls participants who completed the double-blind parent study CTQJ230A12301 to receive pelacarsen 80 mg once monthly. Participants will be followed with clinic visits, safety labs, and adverse-event monitoring to characterize long-term tolerability. Key eligibility requires completion of the parent study while still on the investigational product and excludes those who permanently discontinued or interrupted treatment for six continuous months, those on other investigational agents, or those with conditions that increase risk. The study is sponsored by Novartis and conducted at several U.S. cardiology research sites.

Who should consider this trial

Good fit: Ideal candidates are participants who completed the parent trial CTQJ230A12301 while still on the assigned investigational product, have established cardiovascular disease with elevated Lp(a), and can give informed consent.

Not a fit: Patients who permanently discontinued or interrupted the investigational product for six continuous months during the parent study, those with known sensitivity to pelacarsen, or those on other investigational drugs are not eligible and would not benefit from this extension.

Why it matters

Potential benefit: If successful, the extension could confirm that monthly pelacarsen is safe and tolerable over the long term, allowing continued access for participants and supporting broader use for lowering Lp(a).

How similar studies have performed: Earlier controlled trials of pelacarsen have shown substantial Lp(a) lowering and acceptable short-term safety, but long-term safety and durability data are still being collected.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study EOS visit while still on assigned investigational product.

Exclusion Criteria:

* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
* Participants are receiving another investigational drug or device before the open-label treatment period.
* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Andalusia, Alabama and 491 other locations

+442 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiovascular Disease and LipoproteinLipoprotein,Lp,cardiovascular disease,CVD,myocardial infarction,stroke,OLE,
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.