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NCT07517263 · ClinicalTrials.gov registry record · Phase 3
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 5,700
- Enrollment target
NCT07517263: Recruiting Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT07517263 is a Phase 3 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 5,700 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (638% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07517263, a Phase 3 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,700 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Pelacarsen (TQJ230)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,700 participants |
| Start Date | 2026-05-11 |
| Est. Completion | 2030-01-09 |
| Phase | Phase 3 |
What NCT07517263 shows while recruiting
NCT07517263 is an interventional study that assigns participants to a tested intervention. Its 5,700 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (638% higher).
The record links to 0 conditions, and to 1 intervention - of which Pelacarsen (TQJ230) is the first listed.
NCT07517263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07517263 about?
NCT07517263 is a clinical study titled "An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)". 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).
What is the current status of trial NCT07517263?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 5,700 participants. The study started on 2026-05-11. Estimated completion is 2030-01-09.
What interventions are being tested in trial NCT07517263?
The interventions under investigation include: Pelacarsen (TQJ230) (DRUG).
Who is sponsoring clinical trial NCT07517263?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07517263's enrollment target sits among peer trials
5,700 42nd of 2000 higher than 1,959 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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