Pelacarsen Roll-over Extension Program

May 14, 2026 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Study Type

Interventional

Enrollment (Estimated)

599

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Recruiting
        • Advanced Clinical Research LLC
        • Principal Investigator:
          • Angel Luis Comulada-Rivera
        • Contact:
      • Humacao, Puerto Rico, 00791
        • Recruiting
        • Dr Yolanda Figueroa Private Pr
        • Principal Investigator:
          • Yolanda Figueroa
        • Contact:
      • Ponce, Puerto Rico, 00717-1322
        • Recruiting
        • Research and Cardiovascular Corp
        • Contact:
        • Principal Investigator:
          • Jose B Vazquez-Tanus
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • CAIMED Center
        • Principal Investigator:
          • Elizabeth A. Barranco
        • Contact:
      • San Juan, Puerto Rico, 00921
        • Recruiting
        • VA Caribbean Healthcare System
        • Principal Investigator:
          • Luis Rodriguez-Ospina
        • Contact:
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Latin Clinical Trial Center Inc
        • Principal Investigator:
          • Alex Gonzalez Bossolo
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Recruiting
        • Parkway Medical Center
        • Principal Investigator:
          • James Sullivan
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Cardiology and Medicine Clinic PA
        • Principal Investigator:
          • Joe L Hargrove
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
      • Canoga Park, California, United States, 91303
      • Covina, California, United States, 91723
      • Garden Grove, California, United States, 92844
        • Recruiting
        • NICRs Research Center
        • Principal Investigator:
          • Mallu Reddy
        • Contact:
      • Irvine, California, United States, 92660
        • Recruiting
        • University of Calif Irvine Med Cntr
        • Contact:
        • Principal Investigator:
          • Ailin Barseghian El-Farra
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Clinical Trials
        • Principal Investigator:
          • Suzanne Fussell
        • Contact:
      • Los Angeles, California, United States, 90026
      • Northridge, California, United States, 91324
        • Recruiting
        • California Medical Research Associates Inc
        • Contact:
        • Principal Investigator:
          • Jigar Kadakia
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Principal Investigator:
          • Abha Khandelwal
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Active, not recruiting
        • Excel Medical Clinical Trials LLC
      • Cape Coral, Florida, United States, 33990
        • Recruiting
        • C and A Clinical Trials
        • Principal Investigator:
          • Juan Antonio Carmona Herrera
        • Contact:
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Proactive Clinical Research
        • Principal Investigator:
          • David Mishkin
        • Contact:
      • Fort Lauderdale, Florida, United States, 33308
        • Active, not recruiting
        • Proactive Clinical Research
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • National Research Institute
        • Principal Investigator:
          • Raul Alonso
        • Contact:
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Sister Life Research Inc
        • Contact:
        • Principal Investigator:
          • Idania Melo Fernandez
      • Hollywood, Florida, United States, 33021
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33125
        • Recruiting
        • Columbus Clinical Services LLC
        • Principal Investigator:
          • Sara Llerena
        • Contact:
      • Miami, Florida, United States, 33186
        • Recruiting
        • A&A Research Group Inc
        • Principal Investigator:
          • Rafael Crespo
        • Contact:
      • Miami, Florida, United States, 33126
        • Active, not recruiting
        • Finlay Medical Research
      • Miami, Florida, United States, 33156
        • Recruiting
        • International Research Associates, LLC
        • Principal Investigator:
          • Cristian Breton
        • Contact:
      • Miami, Florida, United States, 33173
        • Recruiting
        • Baptist Health South
        • Principal Investigator:
          • Adedapo Iluyomade
        • Contact:
      • Miami Lakes, Florida, United States, 33014
      • Miramar, Florida, United States, 33027
        • Recruiting
        • FXM Clin Res Miramar LLC
        • Principal Investigator:
          • Yaneth Trujillo
        • Contact:
      • Palm Springs, Florida, United States, 33406
        • Recruiting
        • CTMD Research
        • Principal Investigator:
          • Luis Castillo
        • Contact:
      • Pembroke Pines, Florida, United States, 33029
        • Recruiting
        • DBC Research USA
        • Principal Investigator:
          • Alvaro Murcia
        • Contact:
      • Tampa, Florida, United States, 33603
      • Tampa, Florida, United States, 33612
        • Recruiting
        • James A Haley Veterans Hospital
        • Principal Investigator:
          • David Whitaker
        • Contact:
      • Wellington, Florida, United States, 33449
        • Recruiting
        • Cardiology Partners Clinical Research Institute
        • Principal Investigator:
          • Duccio Baldari
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine
        • Principal Investigator:
          • Priscilla Igho-Pemu
        • Contact:
      • Tucker, Georgia, United States, 30084
        • Recruiting
        • Atlanta Heart Specialists LLC
        • Principal Investigator:
          • David Suh
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Inst
        • Principal Investigator:
          • Dennis Levinson
        • Contact:
          • Mohammed Hamed Ali Khan
          • Phone Number: +1 312 791 3241
          • Email: akhan@ccrii.us
      • Chicago, Illinois, United States, 60602
        • Active, not recruiting
        • Synexus Clinical Research US Inc
      • Grandwood Park, Illinois, United States, 60031
      • Grandwood Park, Illinois, United States, 60031
        • Active, not recruiting
        • Flourish Research
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Cardiovascular Associates Research
        • Principal Investigator:
          • Dale Presser
        • Contact:
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Omega Clinical Research
        • Principal Investigator:
          • Tuan-Huy Tran
        • Contact:
      • Opelousas, Louisiana, United States, 70570
        • Recruiting
        • CV Ins of the South
        • Principal Investigator:
          • Siby George Ayalloore
        • Contact:
      • West Monroe, Louisiana, United States, 71291
      • Zachary, Louisiana, United States, 70791
        • Active, not recruiting
        • Southern Clin Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Recruiting
        • Ascension Saint Agnes Heart Care
        • Principal Investigator:
          • Martin Albornoz
        • Contact:
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Sinai Ct for Throm Res and Drug Dev
        • Principal Investigator:
          • Paul Gurbel
        • Contact:
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Univ School of Med
        • Principal Investigator:
          • Thorsten Leucker
        • Contact:
      • Beltsville, Maryland, United States, 20705
        • Recruiting
        • Metropolitan Cardiovascular Consultants LLC
        • Principal Investigator:
          • Ayim Akyea-Djamson
        • Contact:
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Daniel Kim
        • Contact:
      • Ft. Washington, Maryland, United States, 20744
      • Lanham, Maryland, United States, 20706
        • Recruiting
        • Capitol Cardiology Associates
        • Principal Investigator:
          • Vineet Venugopal
        • Contact:
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Sachin Parikh
        • Contact:
      • Flint, Michigan, United States, 48504
        • Active, not recruiting
        • Aa Mrc Llc
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Aa Mrc Mhs
        • Principal Investigator:
          • Khalid Ahmed
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Stern Cardiovascular Foundation Inc
        • Principal Investigator:
          • Dharmesh Patel
        • Contact:
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Endocrinology
        • Principal Investigator:
          • Quang Nguyen
        • Contact:
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • AB Clinical Trials
        • Principal Investigator:
          • Atoya Adams
        • Contact:
      • Las Vegas, Nevada, United States, 89121
        • Recruiting
        • Clinical Research of South Nevada
        • Principal Investigator:
          • Roger Estevez
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson Medical School
        • Principal Investigator:
          • Tudor D Vagaonescu
        • Contact:
      • Summit, New Jersey, United States, 07901
    • New York
      • Richmond Hill, New York, United States, 11418
        • Recruiting
        • Jamaica Hospital Medical Center
        • Principal Investigator:
          • David Coven
        • Contact:
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Lima, Ohio, United States, 45801
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
      • Linwood, Pennsylvania, United States, 19061
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Apex Cardiology Research Associates of Jackson
        • Principal Investigator:
          • Mohsin Alhaddad
        • Contact:
    • Texas
      • Allen, Texas, United States, 75002-3688
        • Recruiting
        • Plano Primary Care Clinic
        • Principal Investigator:
          • Muhammad Moin Farooqi
        • Contact:
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Pharma Tex Research
        • Principal Investigator:
          • David Brabham
        • Contact:
      • Bedford, Texas, United States, 76021
        • Active, not recruiting
        • North Hills Medical Research Inc
      • Dallas, Texas, United States, 75235
        • Recruiting
        • SW Family Medicine Associates
        • Principal Investigator:
          • Chrisette Dharma
        • Contact:
      • El Paso, Texas, United States, 79905
        • Recruiting
        • David Turbay MD PLLC
        • Principal Investigator:
          • David Turbay
        • Contact:
      • Houston, Texas, United States, 77025
        • Recruiting
        • Angiocardiac Care of Texas PA
        • Principal Investigator:
          • Amin Karim
        • Contact:
      • Houston, Texas, United States, 77084
        • Recruiting
        • Dallas Heart and Vascular Consultants PA
        • Principal Investigator:
          • Imran Afridi
        • Contact:
      • Lewisville, Texas, United States, 75057
      • Lufkin, Texas, United States, 75904
      • Pflugerville, Texas, United States, 78660-3015
        • Recruiting
        • Discovery Clinical Trials
        • Principal Investigator:
          • Brian K MacGillivray
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78229-3900
        • Recruiting
        • University of Texas Health Science Ctr
        • Contact:
        • Principal Investigator:
          • Carolina Solis-Herrera
    • Virginia
      • Alexandria, Virginia, United States, 22311
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Virginia Heart
        • Principal Investigator:
          • Tariq Haddad
        • Contact:
      • Hopewell, Virginia, United States, 23860
        • Recruiting
        • Heart Care Associates P C
        • Principal Investigator:
          • Kamlesh Dave
        • Contact:
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Vcu Health
        • Contact:
        • Principal Investigator:
          • Phillip Duncan.
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates
        • Principal Investigator:
          • Richard A Jackson
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Francis Kim
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelacarsen (TQJ230)
open-label pelacarsen 80mg
Drug: Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Other Names:
  • TQJ230

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Time Frame: 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
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
Time Frame: Baseline of the core study, Month 3, 12, 24, 36, 48
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
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
Time Frame: Baseline of the REP study, Month 3, 12, 24, 36, 48
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Baseline of the REP study, Month 3, 12, 24, 36, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

December 8, 2030

Study Completion (Estimated)

December 8, 2030

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTQJ230A12305B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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