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Long-term Safety of Pelacarsen for Cardiovascular Disease

This study is an extension for people who have already completed a previous study involving pelacarsen (TQJ230). It aims to understand the long-term safety and how well your body tolerates pelacarsen, a drug given monthly by injection under the skin. You may be able to join if you have cardiovascular disease (heart and blood vessel conditions) and high lipoprotein(a) (Lp(a)), and successfully finished the earlier study while still taking the assigned treatment. The main goal is to track any side effects you might experience for up to 36 months. The study plans to include about 5700 participants. The current recruitment status is unclear.

Study design
This is an open-label extension study, meaning both you and the study team will know you are receiving pelacarsen. It plans to include about 5700 participants.
What's involved
You will receive pelacarsen 80mg monthly by injection under the skin. The study will track adverse events for up to 36 months.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 36 months after starting the study.

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NCT07517263

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~5,700 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Pelacarsen (TQJ230)

At a glance

Recruiting sites
485 of 643 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse events
Measured over Up to 36 months

Conditions

Cardiovascular Disease and Lipoprotein(a)

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Where it's being run

643 sites across 209 states
Germany34
Russia33
Czechia29
Slovakia21
United Kingdom21
California14
São Paulo12
Louisiana11

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with Adverse eventsUp to 36 months

    Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.