Last Update: Jul 29, 2026 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 ClinicalTrials.gov Identifier: [NCT06875973](https://clinicaltrials.gov/ct2/show/NCT06875973) Novartis Reference Number:CTQJ230A12305B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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). 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. Condition Atherosclerotic Cardiovascular Disease Phase Phase3 Overall Status Recruiting Number of Participants599 Start Date May 19, 2025 Completion Date Dec 08, 2030 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### Pelacarsen (TQJ230) pelacarsen 80mg s.c. monthly ## 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. Puerto Rico #### Advanced Clinical Research LLC Recruiting Bayamón,00959,Puerto Rico ###### Angel Luis Comulada-Rivera ###### Sonia Ortiz Santos Email: #### Dr Yolanda Figueroa Private Pr Recruiting Humacao,00791,Puerto Rico ###### Noemi Torres Rivas Email: ###### Yolanda Figueroa #### CAIMED Center Recruiting Ponce,00716,Puerto Rico ###### Elizabeth A. Barranco ###### Nancy Jimenez Phone: [+1 787 840 2580]() Email: #### Research and Cardiovascular Corp Recruiting Ponce,00717-1322,Puerto Rico ###### Jose B Vazquez-Tanus ###### Maria E Diago Phone: [+1 787 259 0526]() Email: [diago\_research@yahoo.com](mailto:diago_research@yahoo.com) #### Latin Clinical Trial Center Inc Recruiting San Juan,00909,Puerto Rico ###### Alex Gonzalez Bossolo ###### Gina Velez Phone: [+1 787 249 4763]() Email: #### VA Caribbean Healthcare System Recruiting San Juan,00921,Puerto Rico ###### Loriany Alcocer-Rodriguez Phone: [+17876417582#10393](tel:+17876417582#10393) Email: ###### Luis Rodriguez-Ospina United States #### Parkway Medical Center Recruiting Birmingham,Alabama,35215,United States ###### James Gregory Sullivan ###### Susanne Dyer Phone: [+1 205 815 5000]() Email: #### National Heart Institute Recruiting Beverly Hills,California,90211,United States ###### Nayeli Aguillon Phone: [+1 301 289 5221]() Email: ###### Norman Lepor #### Proactive Clinical 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