An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

NCT07517263
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
5,700
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Lead sponsor
Novartis Pharmaceuticals
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Start date
2026-05-11
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Number of sites
643
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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).
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Short title
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-01-09
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First posted
2026-04-08
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Registry last updated
2026-07-30
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Primary completion date
2030-01-09
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Start date
2026-05-11
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Participants
5,700
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Participant count basis
Estimated
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Planned participants
5,700
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Protocol amendments
0
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Number of sites
643
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novartis Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07517263
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ClinicalTrials.gov ID
NCT07517263
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Masking description
Open label study
Sources for study design
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  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.

  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No

  • 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.

  • 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
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  • 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
clinicaltrials.gov

Other registry identifiers

  • 2024-519870-38-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)