Overview
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).
Description
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.
Eligibility
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.