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

A single arm, multicenter, open-label extension (OLE) trial to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established CVD who have completed the parent Lp(a)HORIZON study and to evaluate the long-term efficacy of pelacarsen (TQJ230) on 4P-MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death and urgent coronary revascularization requiring hospitalization) To evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a). TQJ230) is commercially available assuming that superiority of pelacarsen (TQJ230) over placebo regarding MACE reduction was demonstrated in the parent study.

· Trial Design:

1. Screening period (up to approximately 30 days): Participants can be screened at or within 3 months of the End of study (EOS) visit of the parent study, or within 3 months of country/local approval of the OLE study if the approval occurs after the EOS visit of the parent study. If screening visit coincides with or occurs within 60 days of the EOS visit of the parent study, the safety assessments completed as part of EOS visit can be used for screening eligibility assessment. If the screening visit occurs later than 60 days from the EOS visit, new safety assessments and medical review will be required to confirm eligibility. Open-label treatment period (minimum 24 months).

2. Treatment of Interest: Pelacarsen (TQJ230) 80 mg QM s.c.

3. Treatment Groups: Participants who completed the parent study will be given open label pelacarsen (TQJ230) 80 mg.

4. Number of Participants: Approximately 5,700 participants from the parent study are expected to participate.

5. Key Inclusion Criteria: Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. Participants who have completed the parent study while still on assigned investigational product.

6. Key Exclusion Criteria: Participants who for any reason permanently discontinued or 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 participants at risk or interfere with the study participation, including, .Participants are receiving another investigational drug or device before the open-label treatment period Pregnant or nursing (breastfeeding) women of childbearing potential unless they are using highly effective methods of contraception

7. Treatment duration: Once enrolled in the study, participants will commence with open label pelacarsen (TQJ230) and may continue on the study until (whichever is sooner): 3 years after LPFV of the participant in the country, or the benefit-risk profile of pelacarsen (TQJ230) is no longer positive, or pelacarsen (TQJ230) becomes commercially available and subsequently reimbursed in the country or, when reimbursement is not possible, the product is launched in the country, or, if a marketing application of an investigator product is rejected in a region/country for the indication under study.

End of study is defined as when the last participant finishes his/her EOS visit, and any repeat assessments associated with this visit have been documented and followed up appropriately by the Investigator. All participants were instructed in regular intervals in the parent study to comply with lifestyle changes according to local and international recommendations, and this is also encouraged in the OLE study. A screen failure occurs when a participant who consents to participate in the OLE study is subsequently found

to be ineligible and therefore not entered in the study. Participants who screen failed due to safety lab assessments can be rescreened. However, the rescreening must be done within 3 months from the country/local approval of the OLE study or EOS visit of the parent study, whichever occurs later. Participants will not be replaced in this study. No additional treatment beyond the open-label pelacarsen (TQJ230) is included in this study