Pelacarsen Roll-over Extension Program

Last Update: Feb 23, 2026

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

ClinicalTrials.gov Identifier:

NCT06875973

Novartis Reference Number:CTQJ230A12305B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). 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.

Condition

Atherosclerotic Cardiovascular Disease

Phase

Phase3

Overall Status

Recruiting

Number of Participants

599

Start Date

May 19, 2025

Completion Date

Dec 08, 2030

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Pelacarsen (TQJ230)

pelacarsen 80mg s.c. monthly

Eligibility Criteria

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.

Advanced Clinical Research LLC

Recruiting

Bayamón,00959,Puerto Rico

Pelacarsen Roll-over Extension Program

Study Description

Interventions

Pelacarsen (TQJ230)

Eligibility Criteria

Advanced Clinical Research LLC

Angel Luis Comulada-Rivera

Sonia Ortiz Santos

Dr Yolanda Figueroa Private Pr

Noemi Torres Rivas

Yolanda Figueroa

CAIMED Center

Elizabeth A. Barranco

Nancy Jimenez

Research and Cardiovascular Corp

Jose B Vazquez-Tanus

Maria E Diago

Latin Clinical Trial Center Inc

Alex Gonzalez Bossolo

Gina Velez

VA Caribbean Healthcare System

Loriany Alcocer-Rodriguez

Luis Rodriguez-Ospina

Parkway Medical Center

James Sullivan

Susanne Dyer

National Heart Institute

Nayeli Aguillon

Norman Lepor

Proactive Clinical Research

David Mishkin

Jose Carbone

Maria Coimbra

Naila Pelegrin

Sister Life Research Inc

Andrea Orellana

Idania Melo Fernandez

Leonor Balbuena

Raul Alonso

Inpatient Research Clinical LLC

Alexis Gutierrez

Dora Gutierrez

Jose Contreras

Sergio Ramirez

DBC Research USA

Alvaro Murcia

Antonio Marrero

Cardiology Partners Clinical Research Institute

Duccio Baldari

Saaima Farooq

Cardiovascular Associates Research

Dale Presser

Vicki L Nicely

Southern Clin Research Clinic

Brandi Kenney

Ernest Thompson

Capitol Cardiology Associates

Iluyomade Adeusi

Vineet Venugopal

Henry Ford Hospital

Meghan McCarthy

Sachin Parikh

Aa Mrc Llc

Ahmed A Arif

Fayyaz Shah

AB Clinical Trials

Atoya Adams

Nelmis Diaz

Clinical Research of South Nevada

Roger Estevez

Zeida Gonzalez

Apex Cardiology Research Associates of Jackson

Mohsin Alhaddad

Pam Gibbons

Angiocardiac Care of Texas PA

Alexis Sincere

Amin Karim

Clinical Trials of Texas

Douglas Denham

Victoria Dilks