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Active, not recruiting Phase 3

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

NCT07517263 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-05-11
Last updated
2026-10-14

Condition(s) studied

Cardiovascular Disease and Lipoprotein(a)

Investigational drug(s) / intervention(s)

Pelacarsen (TQJ230) →

Pelacarsen (TQJ230): pelacarsen 80mg s.c. monthly

Study summary

This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

Eligibility

Sex
ALL
Min age
18 Years
Max 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.

Primary outcome measure(s)

  • Number of participants with Adverse events — 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.

Trial sites (646)

FacilityCityRegionStatus
SEC Clinical Research LLC Andalusia Alabama
Heart Center Research Llc Huntsville Alabama
Mobile Heart Specialists Mobile Alabama
Mercy Gilbert Medical Center Gilbert Arizona
Clinical Research Inst of Arizona Sun City West Arizona
Eclipse Clinical Research Tucson Arizona
Cardiology and Medicine Clinic PA Little Rock Arkansas
Cardiovascular Res Found Beverly Hills California
National Heart Institute Beverly Hills California
Valley Clinical Trials Inc Covina California
Diabetes Lipid Management Center Huntington Beach California
University of Calif Irvine Med Cntr Irvine California
Memorial Care Health System Long Beach California
Keck Medical Center USC Los Angeles California
Valley Clinical Trials Northridge California
Stanford University Medical Center Palo Alto California
University of California San Diego San Diego California
UCSF San Francisco California
Manshadi Heart Institute Stockton California
Interv Cardiology Med Grp West Hills California
Univ Of Color Anschutz Med Center Aurora Colorado
Bridgeport Hospital Bridgeport Connecticut
Hartford Hospital Hartford Connecticut
Chase Medical Research LLC Waterbury Connecticut
Excel Medical Clinical Trials LLC Boca Raton Florida
Bay Area Cardiology Assoc Brandon Florida
Jacksonville Center for Clinical Research Jacksonville Florida
Advanced Research for Health Improvement LLC Naples Florida
Peace River Cardiovascular Center Port Charlotte Florida
Progressive Medical Research Port Orange Florida
East Coast Inst for Research LLC Saint Augustine Florida
Cardiology Partners Clinical Research Institute Wellington Florida
Piedmont Heart Institute Atlanta Georgia
Emory University Atlanta Georgia
Cardiovascular Consultants of S GA Thomasville Georgia
Rush University Medical Center Chicago Illinois
Advocate Lutheran General Childrens Hospital Park Ridge Illinois
Krannert Institute of Cardiology Indianapolis Indiana
Uni Of Iowa Hospitals And Clinics Iowa City Iowa
University of Kansas Hospital Kansas City Kansas

+ 606 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517263 on ClinicalTrials.gov ↗ ← All trials in the UK