NCT07517263 An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
| NCT ID | NCT07517263 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Cardiovascular Disease and Lipoprotein(a) |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,700 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2030-01-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5,700 participants in total. It began in 2026-05-11 with a primary completion date of 2030-01-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
Eligibility 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07517263 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cardiovascular Disease and Lipoprotein(a). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07517263 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5,700 participants.
Is NCT07517263 currently recruiting?
Yes, NCT07517263 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07517263 trial being conducted?
This trial is being conducted at Andalusia, United States, Huntsville, United States, Mobile, United States, Gilbert, United States and 11 additional locations.
Who is sponsoring the NCT07517263 clinical trial?
NCT07517263 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 5,700 participants.