Pelacarsen Roll-over Extension Program
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
Sponsor: Novartis Pharmaceuticals
This observational or N/A phase trial investigates Atherosclerotic Cardiovascular Disease and is currently actively recruiting participants. Novartis Pharmaceuticals leads this study, which shows 4 recorded versions since 2025 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Study Description(click to expand)This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.
Status Flow
Change History
4 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
-
Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE3
-
Sep 2025 — Feb 2026 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Apr 2025 — Sep 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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).
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .