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

Recruiting now · Phase 3

Conditions studied: Cardiovascular Disease and Lipoprotein(a)

In brief

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).

Key facts

Study ID

NCT07517263

Run by

Novartis Pharmaceuticals

People needed

5700

Starts

2026-05-11

Expected to finish

2030-01-09

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SEC Clinical Research LLC — Andalusia, Alabama, United States (enrolling)
• Excel Medical Clinical Trials LLC — Boca Raton, Florida, United States (enrolling)
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States (enrolling)
• Heart Center Research Llc — Huntsville, Alabama, United States (enrolling)
• Eclipse Clinical Research — Tucson, Arizona, United States (enrolling)
• Mobile Heart Specialists — Mobile, Alabama, United States (enrolling)
• Cardiovascular Res Found — Beverly Hills, California, United States (enrolling)
• National Heart Institute — Beverly Hills, California, United States (enrolling)
• Clinical Research Inst of Arizona — Sun City West, Arizona, United States (enrolling)
• Diabetes Lipid Management Center — Huntington Beach, California, United States (enrolling)
• University of Calif Irvine Med Cntr — Irvine, California, United States (enrolling)
• Memorial Care Health System — Long Beach, California, United States (enrolling)
• Keck Medical Center USC — Los Angeles, California, United States (enrolling)
• Cardiology and Medicine Clinic PA — Little Rock, Arkansas, United States (enrolling)
• Stanford University Medical Center — Palo Alto, California, United States (enrolling)
• University of California San Diego — San Diego, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• Helping Hands Medical Associates INC — Santa Ana, California, United States (enrolling)
• Manshadi Heart Institute — Stockton, California, United States (enrolling)
• Interv Cardiology Med Grp — West Hills, California, United States (enrolling)
• Univ Of Color Anschutz Med Center — Aurora, Colorado, United States (enrolling)
• Bridgeport Hospital — Bridgeport, Connecticut, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Chase Medical Research LLC — Waterbury, Connecticut, United States (enrolling)
• Bay Area Cardiology Assoc — Brandon, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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