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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• SEC Clinical Research LLC, Andalusia, Alabama, United States
• Heart Center Research Llc, Huntsville, Alabama, United States
• Mobile Heart Specialists, Mobile, Alabama, United States
• Mercy Gilbert Medical Center, Gilbert, Arizona, United States
• Clinical Research Inst of Arizona, Sun City West, Arizona, United States
• Eclipse Clinical Research, Tucson, Arizona, United States
• Cardiology and Medicine Clinic PA, Little Rock, Arkansas, United States
• Cardiovascular Res Found, Beverly Hills, California, United States
• National Heart Institute, Beverly Hills, California, United States
• Valley Clinical Trials Inc, Covina, California, United States
• Diabetes Lipid Management Center, Huntington Beach, California, United States
• University of Calif Irvine Med Cntr, Irvine, California, United States

+ 623 more sites.

Who to contact

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07517263.