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Clinical Trials in the USA / NCT06875973
Active, not recruiting Phase 3

Pelacarsen Roll-over Extension Program

NCT06875973 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-05-19
Last updated
2026-10-14

Condition(s) studied

Atherosclerotic Cardiovascular Disease

Investigational drug(s) / intervention(s)

Pelacarsen (TQJ230) →

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

Study summary

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). 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 and received the assigned study treatment at the time of its completion Exclusion Criteria: * Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study * Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation * Participants who are receiving another investigational drug or device before the open-label treatment period * Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Incidence of Adverse events (AEs) or serious adverse events (SAEs) — Up to 48 months
    Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study

Trial sites (89)

FacilityCityRegionStatus
Parkway Medical Center Birmingham Alabama
Cardiology and Medicine Clinic PA Little Rock Arkansas
National Heart Institute Beverly Hills California
Hope Clinical Research Canoga Park California
Valley Clinical Trials Inc Covina California
NICRs Research Center Garden Grove California
University of Calif Irvine Med Cntr Irvine California
Long Beach Clinical Trials Long Beach California
Angel City Research Inc Los Angeles California
California Medical Research Associates Inc Northridge California
Stanford Health Care Stanford California
Excel Medical Clinical Trials LLC Boca Raton Florida
C and A Clinical Trials Cape Coral Florida
Proactive Clinical Research Fort Lauderdale Florida
National Research Institute Hialeah Florida
Sister Life Research Inc Hialeah Florida
Zenith Clinical Research Hollywood Florida
Columbus Clinical Services LLC Miami Florida
Finlay Medical Research Miami Florida
Infinite Clinical Research Miami Florida
International Research Associates LLC Miami Florida
Baptist Health South Miami Florida
A&A Research Group Inc Miami Florida
Inpatient Research Clinical LLC Miami Lakes Florida
FXM Clin Res Miramar LLC Miramar Florida
CTMD Research Palm Springs Florida
DBC Research USA Pembroke Pines Florida
New Tampa Health Tampa Florida
James A Haley Veterans Hospital Tampa Florida
Cardiology Partners Clinical Research Institute Wellington Florida
Flourish Research Winter Park Florida
Morehouse School Of Medicine Atlanta Georgia
Atlanta Heart Specialists LLC Tucker Georgia
Synexus Clinical Research US Inc Chicago Illinois
Chicago Clinical Research Inst Chicago Illinois
Cardiovascular Associates Research Covington Louisiana
Omega Clinical Research Metairie Louisiana
CV Ins of the South Opelousas Louisiana
Monroe Research Llc West Monroe Louisiana
Southern Clin Research Clinic Zachary Louisiana

+ 49 more sites — see the full list on the official registry below.

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Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN Recruiting

Other trials for the same condition

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity Active, not recruiting
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease Active, not recruiting
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial Active, not recruiting
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 NCT06875973 on ClinicalTrials.gov ↗ ← All trials in the USA