NCT06875973 Pelacarsen Roll-over Extension Program
| NCT ID | NCT06875973 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Atherosclerotic Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 599 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2030-12-08 |
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 599 participants in total. It began in 2025-05-19 with a primary completion date of 2030-12-08.
⚠ 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 non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06875973 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atherosclerotic Cardiovascular Disease. 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 NCT06875973 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 599 participants.
Is NCT06875973 currently recruiting?
Yes, NCT06875973 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06875973 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Beverly Hills, United States, Canoga Park, United States and 11 additional locations.
Who is sponsoring the NCT06875973 clinical trial?
NCT06875973 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 599 participants.