Recruiting
Phase 3

Pelacarsen

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06875973

Conditions

Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pelacarsen (TQJ230)

Study Details

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).

Conditions

Atherosclerotic Cardiovascular Disease

Study ID

NCT06875973

Start date

May 19, 2025

Status verified date

Jul, 2026

Completion date

Dec 8, 2030

Anticipated

Primary completion date

Dec 8, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

599 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pelacarsen (TQJ230)

open-label pelacarsen 80mg

Interventions

Pelacarsen (TQJ230)

pelacarsen 80mg s.c. monthly

Primary outcome measure

  • Incidence of Adverse events (AEs) or serious adverse events (SAEs) [ Time Frame: Up to 48 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

Parkway Medical Center

Recruiting

Birmingham, Alabama, United States, 35215

Contacts

Principal Investigator:

James Gregory Sullivan

Cardiology and Medicine Clinic PA

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Principal Investigator:

Joe L Hargrove

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Norman Lepor

Hope Clinical Research

Recruiting

Canoga Park, California, United States, 91303

Contacts

Principal Investigator:

Hessam Aazami

University of Calif Irvine Med Cntr

Recruiting

Irvine, California, United States, 92660

Contacts

Principal Investigator:

Ailin Barseghian El-Farra

Long Beach Clinical Trials

Recruiting

Long Beach, California, United States, 90806

Contacts

Principal Investigator:

Suzanne Fussell

Angel City Research Inc

Recruiting

Los Angeles, California, United States, 90026

Contacts

Principal Investigator:

Felix Sigal

Stanford Health Care

Recruiting

Stanford, California, United States, 94305

Contacts

Tamara Bazouzi

bazouzit@stanford.edu

Principal Investigator:

Abha Khandelwal

C and A Clinical Trials

Recruiting

Cape Coral, Florida, United States, 33990

Contacts

Sildey Mas Hernandez

sildey@caclinicaltrial.com

Principal Investigator:

Juan Antonio Carmona Herrera

Proactive Clinical Research

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Principal Investigator:

David Mishkin

National Research Institute

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Principal Investigator:

Raul Alonso

Sister Life Research Inc

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Principal Investigator:

Idania Melo Fernandez

Zenith Clinical Research

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Principal Investigator:

Moises Issa

Columbus Clinical Services LLC

Recruiting

Miami, Florida, United States, 33125

Contacts

Principal Investigator:

Sara Llerena

Infinite Clinical Research

Recruiting

Miami, Florida, United States, 33133

Contacts

Principal Investigator:

Sander Fernandez

International Research Associates LLC

Recruiting

Miami, Florida, United States, 33156

Contacts

Principal Investigator:

Cristian Breton

Baptist Health South

Recruiting

Miami, Florida, United States, 33173

Contacts

Principal Investigator:

Adedapo Iluyomade

A&A Research Group Inc

Recruiting

Miami, Florida, United States, 33186

Contacts

Principal Investigator:

Rafael Crespo

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Principal Investigator:

Alexis Gutierrez

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Principal Investigator:

Jose Contreras

CTMD Research

Recruiting

Palm Springs, Florida, United States, 33406

Contacts

Principal Investigator:

Luis Castillo

DBC Research USA

Recruiting

Pembroke Pines, Florida, United States, 33029

Contacts

Principal Investigator:

Alvaro Murcia

New Tampa Health

Recruiting

Tampa, Florida, United States, 33603

Contacts

Principal Investigator:

Esther Echevarria-Crespo

James A Haley Veterans Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

David Whitaker

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Contacts

Principal Investigator:

Duccio Baldari

Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Principal Investigator:

Sara Collins

Morehouse School Of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Principal Investigator:

Priscilla Igho-Pemu

Atlanta Heart Specialists LLC

Recruiting

Tucker, Georgia, United States, 30084

Contacts

Principal Investigator:

David Suh

Chicago Clinical Research Inst

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Principal Investigator:

Dennis Levinson

Cardiovascular Associates Research

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Principal Investigator:

Dale Presser

Omega Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Principal Investigator:

Tuan-Huy Tran

CV Ins of the South

Recruiting

Opelousas, Louisiana, United States, 70570

Contacts

Principal Investigator:

Siby George Ayalloore

Monroe Research Llc

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Principal Investigator:

Assad Mouhaffel

Sinai Ct for Throm Res and Drug Dev

Recruiting

Baltimore, Maryland, United States, 21209

Contacts

Principal Investigator:

Paul Gurbel

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

Principal Investigator:

Martin Albornoz

Johns Hopkins Univ School of Med

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Thorsten Leucker

Metropolitan Cardiovascular Consultants Llc

Recruiting

Beltsville, Maryland, United States, 20705

Contacts

Principal Investigator:

Ayim Akyea-Djamson

Johns Hopkins University

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Principal Investigator:

Daniel Kim

Capitol Cardiology Associates

Recruiting

Lanham, Maryland, United States, 20706

Contacts

Principal Investigator:

Vineet Venugopal

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

Contacts

Principal Investigator:

John Hakim

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Meghan McCarthy

mmccart8@hfhs.org

Principal Investigator:

Sachin Parikh

Aa Mrc Mhs

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Khalid Ahmed

Elite Clinical Research

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Principal Investigator:

Honey East

Stern Cardiovascular Foundation Inc

Recruiting

Southaven, Mississippi, United States, 38671

Contacts

Principal Investigator:

Dharmesh Patel

Las Vegas Endocrinology

Recruiting

Henderson, Nevada, United States, 89074

Contacts

Principal Investigator:

Quang Nguyen

AB Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Principal Investigator:

Atoya Adams

Clinical Research of South Nevada

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

Principal Investigator:

Roger Estevez

Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Glaucia Dos Santos-Vaccaro

gd301@rwjms.rutgers.edu

Principal Investigator:

Tudor D Vagaonescu

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Principal Investigator:

Robert Fishberg

Jamaica Hospital Medical Center

Recruiting

Richmond Hill, New York, United States, 11418

Contacts

Principal Investigator:

David Coven

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Alliance Medical Ministry

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Principal Investigator:

Edwin Burkett

NexGen Research

Recruiting

Lima, Ohio, United States, 45801

Contacts

Principal Investigator:

Nonso Ezema

Care Access Research

Recruiting

Easton, Pennsylvania, United States, 18045

Contacts

Principal Investigator:

Jimmy Alele

TCV Clinical Studies

Recruiting

Linwood, Pennsylvania, United States, 19061

Contacts

Principal Investigator:

Edward Stankiewicz

Apex Cardiology Research Associates of Jackson

Recruiting

Jackson, Tennessee, United States, 38301

Contacts

Plano Primary Care Clinic

Recruiting

Allen, Texas, United States, 75002-3688

Contacts

Principal Investigator:

Muhammad Moin Farooqi

Pharma Tex Research

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Principal Investigator:

David Brabham

SW Family Medicine Associates

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Chrisette Dharma

David Turbay MD PLLC

Recruiting

El Paso, Texas, United States, 79905

Contacts

Principal Investigator:

David Turbay

Angiocardiac Care of Texas PA

Recruiting

Houston, Texas, United States, 77025

Contacts

Principal Investigator:

Amin Karim

Dallas Heart and Vascular Consultants PA

Recruiting

Houston, Texas, United States, 77084

Contacts

Principal Investigator:

Syed Humayun Naqvi

Dallas Heart and Vascular Consultants PA

Recruiting

Houston, Texas, United States, 77084

Contacts

Principal Investigator:

Imran Afridi

Epic Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

Contacts

Principal Investigator:

Manjoo Sharma

The Heart Institute of East Texas

Recruiting

Lufkin, Texas, United States, 75904

Contacts

Principal Investigator:

Mohammed Khan

Discovery Clinical Trials

Recruiting

Pflugerville, Texas, United States, 78660-3015

Contacts

Principal Investigator:

Brian K MacGillivray

University of Texas Health Science Ctr

Recruiting

San Antonio, Texas, United States, 78229-3900

Contacts

William Murff

murff@uthscsa.edu

Principal Investigator:

Carolina Solis-Herrera

Javara Research

Recruiting

Alexandria, Virginia, United States, 22311

Contacts

Principal Investigator:

Amine Segueni

Javara Research

Recruiting

Alexandria, Virginia, United States, 22311

Contacts

Principal Investigator:

Aslam Khan

Javara Research

Recruiting

Alexandria, Virginia, United States, 22311

Contacts

Principal Investigator:

Monique Langston

Javara Research

Recruiting

Alexandria, Virginia, United States, 22311

Contacts

Principal Investigator:

Benjamin Marcum

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Tariq Haddad

Heart Care Associates P C

Recruiting

Hopewell, Virginia, United States, 23860

Contacts

Principal Investigator:

Kamlesh Dave

Vcu Health

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Joshua West

westj6@vcu.edu

Principal Investigator:

Phillip Duncan

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Daniel Isquith

disquith@uw.edu

Principal Investigator:

Francis Kim

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • TQJ230
  • Lp(a)
  • ASCVD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-29.