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Clinical Trials in the UK / NCT07517263
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
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2026-05-11
Last updated
2026-09-04

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 will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

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)

Trial sites (655)

FacilityCityRegionStatus
SEC Clinical Research LLC Andalusia Alabama Recruiting
Heart Center Research Llc Huntsville Alabama Recruiting
Mobile Heart Specialists Mobile Alabama Recruiting
Mercy Gilbert Medical Center Gilbert Arizona Recruiting
Clinical Research Inst of Arizona Sun City West Arizona Recruiting
Eclipse Clinical Research Tucson Arizona Recruiting
Cardiology and Medicine Clinic PA Little Rock Arkansas Recruiting
Cardiovascular Res Found Beverly Hills California Recruiting
National Heart Institute Beverly Hills California Recruiting
Valley Clinical Trials Inc Covina California Active Not Recruiting
Diabetes Lipid Management Center Huntington Beach California Recruiting
University of Calif Irvine Med Cntr Irvine California Recruiting
Memorial Care Health System Long Beach California Recruiting
Keck Medical Center USC Los Angeles California Recruiting
Valley Clinical Trials Northridge California Active Not Recruiting
Stanford University Medical Center Palo Alto California Recruiting
University of California San Diego San Diego California Recruiting
UCSF San Francisco California Recruiting
Helping Hands Medical Associates INC Santa Ana California Withdrawn
Manshadi Heart Institute Stockton California Recruiting
Interv Cardiology Med Grp West Hills California Active Not Recruiting
Univ Of Color Anschutz Med Center Aurora Colorado Recruiting
Bridgeport Hospital Bridgeport Connecticut Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Chase Medical Research LLC Waterbury Connecticut Recruiting
Excel Medical Clinical Trials LLC Boca Raton Florida Recruiting
Bay Area Cardiology Assoc Brandon Florida Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Advanced Research for Health Improvement LLC Naples Florida Recruiting
Peace River Cardiovascular Center Port Charlotte Florida Recruiting
Progressive Medical Research Port Orange Florida Recruiting
East Coast Inst for Research LLC Saint Augustine Florida Recruiting
Cardiology Partners Clinical Research Institute Wellington Florida Recruiting
Piedmont Heart Institute Atlanta Georgia Active Not Recruiting
Emory University Atlanta Georgia Recruiting
Cardiovascular Consultants of S GA Thomasville Georgia Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Advocate Lutheran General Childrens Hospital Park Ridge Illinois Recruiting
Krannert Institute of Cardiology Indianapolis Indiana Recruiting
Uni Of Iowa Hospitals And Clinics Iowa City Iowa Active Not Recruiting

+ 615 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

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