Pelacarsen Roll-over Extension Program
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD
1 other identifier
interventional
599
2 countries
97
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2025
Longer than P75 for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 14, 2025
CompletedStudy Start
First participant enrolled
May 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 8, 2030
May 18, 2026
May 1, 2026
5.6 years
March 12, 2025
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
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
Up to 48 months
Secondary Outcomes (2)
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
Baseline of the core study, Month 3, 12, 24, 36, 48
Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study
Baseline of the REP study, Month 3, 12, 24, 36, 48
Study Arms (1)
Pelacarsen (TQJ230)
EXPERIMENTALopen-label pelacarsen 80mg
Interventions
Eligibility Criteria
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 and received the assigned study treatment at the time of its completion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, 72204, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Valley Clinical Trials Inc
Covina, California, 91723, United States
NICRs Research Center
Garden Grove, California, 92844, United States
University of Calif Irvine Med Cntr
Irvine, California, 92660, United States
Long Beach Clinical Trials
Long Beach, California, 90806, United States
Angel City Research Inc
Los Angeles, California, 90026, United States
California Medical Research Associates Inc
Northridge, California, 91324, United States
Stanford Health Care
Stanford, California, 94305, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
C and A Clinical Trials
Cape Coral, Florida, 33990, United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308, United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308, United States
National Research Institute
Hialeah, Florida, 33013, United States
Sister Life Research Inc
Hialeah, Florida, 33013, United States
Zenith Clinical Research
Hollywood, Florida, 33021, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Infinite Clinical Research
Miami, Florida, 33133, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Baptist Health South
Miami, Florida, 33173, United States
A&A Research Group Inc
Miami, Florida, 33186, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
FXM Clin Res Miramar LLC
Miramar, Florida, 33027, United States
CTMD Research
Palm Springs, Florida, 33406, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
New Tampa Health
Tampa, Florida, 33603, United States
James A Haley Veterans Hospital
Tampa, Florida, 33612, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
Morehouse School Of Medicine
Atlanta, Georgia, 30310, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, 30084, United States
Synexus Clinical Research US Inc
Chicago, Illinois, 60602, United States
Chicago Clinical Research Inst
Chicago, Illinois, 60607, United States
Flourish Research
Grandwood Park, Illinois, 60031, United States
Flourish Research
Grandwood Park, Illinois, 60031, United States
Cardiovascular Associates Research
Covington, Louisiana, 70433, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
CV Ins of the South
Opelousas, Louisiana, 70570, United States
Monroe Research Llc
West Monroe, Louisiana, 71291, United States
Southern Clin Research Clinic
Zachary, Louisiana, 70791, United States
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland, 21209, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229, United States
Johns Hopkins Univ School of Med
Baltimore, Maryland, 21287, United States
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, 20705, United States
Johns Hopkins University
Columbia, Maryland, 21044, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Aa Mrc Mhs
Flint, Michigan, 48503, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
Elite Clinical Research
Jackson, Mississippi, 39202, United States
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, 38671, United States
Las Vegas Endocrinology
Henderson, Nevada, 89074, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Jamaica Hospital Medical Center
Richmond Hill, New York, 11418, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Alliance Medical Ministry
Raleigh, North Carolina, 27610, United States
NexGen Research
Lima, Ohio, 45801, United States
Care Access Research
Easton, Pennsylvania, 18045, United States
TCV Clinical Studies
Linwood, Pennsylvania, 19061, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301, United States
Plano Primary Care Clinic
Allen, Texas, 75002-3688, United States
Pharma Tex Research
Amarillo, Texas, 79106, United States
North Hills Medical Research Inc
Bedford, Texas, 76021, United States
SW Family Medicine Associates
Dallas, Texas, 75235, United States
David Turbay MD PLLC
El Paso, Texas, 79905, United States
Angiocardiac Care of Texas PA
Houston, Texas, 77025, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, 77084, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, 77084, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, 77084, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
The Heart Institute of East Texas
Lufkin, Texas, 75904, United States
Discovery Clinical Trials
Pflugerville, Texas, 78660-3015, United States
University of Texas Health Science Ctr
San Antonio, Texas, 78229-3900, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Javara Research
Alexandria, Virginia, 22311, United States
Javara Research
Alexandria, Virginia, 22311, United States
Javara Research
Alexandria, Virginia, 22311, United States
Javara Research
Alexandria, Virginia, 22311, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Heart Care Associates P C
Hopewell, Virginia, 23860, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
Vcu Health
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195, United States
Advanced Clinical Research LLC
Bayamón, 00959, Puerto Rico
Dr Yolanda Figueroa Private Pr
Humacao, 00791, Puerto Rico
CAIMED Center
Ponce, 00716, Puerto Rico
Research and Cardiovascular Corp
Ponce, 00717-1322, Puerto Rico
Latin Clinical Trial Center Inc
San Juan, 00909, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label study
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 14, 2025
Study Start
May 19, 2025
Primary Completion (Estimated)
December 8, 2030
Study Completion (Estimated)
December 8, 2030
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.