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Pelacarsen Roll-over Extension Program
RecruitingPhase 3
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
Who can join
Ages 18 to 100 · All sexes
Full 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.
About the study
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).
What is being tested
- Pelacarsen (TQJ230) (drug)
Sponsor: Novartis Pharmaceuticals · Participants: 599 · Started: May 19, 2025
Contact the study team
- Novartis Pharmaceuticals · Phone: 1-888-669-6682
- Novartis Pharmaceuticals · Phone: +41613241111
Official record on ClinicalTrials.gov — NCT06875973
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.