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Pelacarsen open-label rollover extension for people with high Lp(a) and ASCVD

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

Phase 3 Interventional Novartis · NCT06875973

This open-label rollover lets people with established ASCVD and high Lp(a) who finished the parent trials receive monthly pelacarsen 80 mg to see if it remains safe and tolerable over the long term.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment599 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations97 sites (Birmingham, Alabama and 96 other locations)
Trial IDNCT06875973 on ClinicalTrials.gov

What this trial studies

This non-randomized, open-label extension enrolls participants who completed the double-blind parent trials CTQJ230A12303 or CTQJ230A12304 and provides monthly pelacarsen 80 mg. The main focus is long-term safety and tolerability while offering post-trial access to the investigational drug. All consenting participants who meet the protocol criteria will be treated and undergo periodic safety assessments and monitoring at study visits. Participants who permanently discontinued pelacarsen in the parent trials or who have investigator-identified contraindications are excluded.

Who should consider this trial

Good fit: Ideal candidates are adults with established atherosclerotic cardiovascular disease and elevated Lp(a) who completed the specified parent trials and did not permanently stop pelacarsen.

Not a fit: Patients who permanently discontinued pelacarsen in the parent trials for protocol-mandated reasons or adverse events, those judged at risk by the investigator, those receiving another investigational therapy, or those with known sensitivity to the drug are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the extension could confirm longer-term safety and provide participants continued access to pelacarsen while informing whether it is a sustainable treatment option.

How similar studies have performed: Earlier phase studies of pelacarsen and other Lp(a)-lowering agents have demonstrated substantial reductions in Lp(a) levels, but long-term safety and effects on cardiovascular events are still being defined.

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

Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 96 other locations

+47 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 Atherosclerotic Cardiovascular DiseaseTQJ230LpASCVD
Last reviewed 2026-06-14 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.