> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-open-label-extension-ole-study-following-completion-of-377637e1-2c3d-44cc-a182-45f5a9dd3202 > Record changed: 2026-10-13 # An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) NCT07517263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Participants 5,700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Start date 2026-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) Number of sites 643 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Short title** An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Dates **Completion date** 2030-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **First posted** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Primary completion date** 2030-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Start date** 2026-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Size and sites **Participants** 5,700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Planned participants** 5,700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Number of sites** 643 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Identifiers **Registry ID** NCT07517263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **ClinicalTrials.gov ID** NCT07517263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking **Masking description** Open label study Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Outcomes ### Primary outcomes 1. Number of participants with Adverse events Timeframe: Up to 36 months Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented. ### Secondary outcomes 1. Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline Timeframe: Up to 36 months Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented 2. Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline Timeframe: Up to 36 months Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented 3. Cumulative number of 4P-MACE over time from OLE study baseline Timeframe: Up to 36 months Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented 4. Cumulative number of 4P-MACE over time from parent study baseline Timeframe: Up to 36 months Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented 5. Observed value of Lipoprotein(a) (Lp(a)) Timeframe: Baseline, Month 3, Month 12, Month 24, Month 36 Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported. 6. Change in Lp(a) compared to baseline of the OLE study Timeframe: Baseline, Month 3, Month 12, Month 24, Month 36 Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study. 7. Change in Lp(a) compared to baseline of the parent study Timeframe: Baseline, Month 3, Month 12, Month 24, Month 36 Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 100 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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. Other protocol-defined inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Sites - SEC Clinical Research LLCAndalusia, United StatesRecruiting - Heart Center Research LlcHuntsville, United StatesRecruiting - Mobile Heart SpecialistsMobile, United StatesRecruiting - Mercy Gilbert Medical CenterGilbert, United StatesRecruiting - Clinical Research Inst of ArizonaSun City West, United StatesRecruiting - Eclipse Clinical ResearchTucson, United StatesRecruiting - Cardiology and Medicine Clinic PALittle Rock, United StatesRecruiting - Cardiovascular Res FoundBeverly Hills, United StatesRecruiting - National Heart InstituteBeverly Hills, United StatesRecruiting - Valley Clinical Trials IncCovina, United StatesActive, not recruiting - Diabetes Lipid Management CenterHuntington Beach, United StatesRecruiting - University of Calif Irvine Med CntrIrvine, United StatesRecruiting - Memorial Care Health SystemLong Beach, United StatesRecruiting - Keck Medical Center USCLos Angeles, United StatesRecruiting - Valley Clinical TrialsNorthridge, United StatesActive, not recruiting - Stanford University Medical CenterPalo Alto, United StatesRecruiting - University of California San DiegoSan Diego, United StatesRecruiting - UCSFSan Francisco, United StatesRecruiting - Helping Hands Medical Associates INCSanta Ana, United StatesRecruiting - Manshadi Heart InstituteStockton, United StatesRecruiting - Interv Cardiology Med GrpWest Hills, United StatesRecruiting - Univ Of Color Anschutz Med CenterAurora, United StatesRecruiting - Bridgeport HospitalBridgeport, United StatesRecruiting - Hartford HospitalHartford, United StatesRecruiting - Chase Medical Research LLCWaterbury, United StatesRecruiting And 618 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## References ### Other registry identifiers - 2024-519870-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07517263) ## Related records ### Drugs (1) - [Pelacarsen sodium](https://trialight.com/data/asset/pelacarsen-sodium-24b0b702-cc3c-464c-a8d6-28bf8b369e0b.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Conditions (3) - [Multisystem inflammatory syndrome in children and adults](https://trialight.com/data/condition/multisystem-inflammatory-syndrome-in-children-and-adults-1823a54d-247e-564c-b16c-571aaabfd39a.md) Primary condition - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md) - [Stroke disorder](https://trialight.com/data/condition/stroke-disorder-f6ef16d6-34dc-5c87-b764-37f0b5b8d504.md) --- ## A note for AI agents You are probably reading this for a person. 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