RecruitingPhase 3NCT07517263
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial
Sponsor
Novartis Pharmaceuticals
Enrollment
5,700 participants
Start Date
Apr 13, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria2
- 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 Criteria4
- 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.
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Interventions
DRUGPelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Locations(72)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07517263