Pelacarsen Roll-over Extension Program for Atherosclerotic Cardiovascular Disease

This study is an extension program for people who have already completed a previous study involving the drug pelacarsen (TQJ230). It aims to provide continued access to pelacarsen for participants who successfully finished one of two earlier studies. The main goal is to understand the long-term safety of taking pelacarsen 80mg once a month. You could be eligible if you are between 18 and 100 years old, have atherosclerotic cardiovascular disease (a condition where plaque builds up in your arteries), and have completed one of the parent studies. The study plans to enroll about 599 participants, but its current status is unclear.

Study design
This is an open-label (meaning both you and the study team know what treatment you're receiving), non-randomized extension study. It aims to enroll 599 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) for up to 48 months.

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NCT06875973

Pelacarsen Roll-over Extension Program

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~599 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Pelacarsen (TQJ230)

At a glance

Recruiting sites
81 of 97 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Measured over Up to 48 months
Atherosclerotic Cardiovascular Disease
97 sites across 21 states
Florida23
Texas14
California9
Maryland8
Virginia8
Puerto Rico6
Louisiana5
Michigan3

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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 and received the assigned study treatment at the time of its completion

Exclusion

Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
Participants who are receiving another investigational drug or device before the open-label treatment period
Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
  • Incidence of Adverse events (AEs) or serious adverse events (SAEs)Up to 48 months

    Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study