Recruiting
Phase 3

Pelacarsen

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07517263

Conditions

Cardiovascular Disease and Lipoprotein(a)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pelacarsen (TQJ230)

Study Details

Brief summary:

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

Conditions

Cardiovascular Disease and Lipoprotein(a)

Study ID

NCT07517263

Start date

May 11, 2026

Status verified date

Sep, 2026

Completion date

Jan 9, 2030

Anticipated

Primary completion date

Jan 9, 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 EOS visit while still on assigned investigational product.

Exclusion Criteria:

  • Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
  • Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
  • Participants are receiving another investigational drug or device before the open-label treatment period.
  • Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

5700 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

  • Number of participants with Adverse events [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

SEC Clinical Research LLC

Recruiting

Andalusia, Alabama, United States, 36420

Contacts

Principal Investigator:

Andreas Muench

Heart Center Research Llc

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Principal Investigator:

Vernon R Hunter

Mobile Heart Specialists

Recruiting

Mobile, Alabama, United States, 36608

Contacts

Principal Investigator:

Christopher S Brown

Mercy Gilbert Medical Center

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Principal Investigator:

Nabil Dib

Clinical Research Inst of Arizona

Recruiting

Sun City West, Arizona, United States, 85375

Contacts

Principal Investigator:

Jalal Abbas

Eclipse Clinical Research

Recruiting

Tucson, Arizona, United States, 85745

Contacts

Principal Investigator:

Eve Shapiro

Cardiology and Medicine Clinic PA

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Principal Investigator:

Joe L Hargrove

Cardiovascular Res Found

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Principal Investigator:

Ronald P Karlsberg

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Norman Lepor

Diabetes Lipid Management Center

Recruiting

Huntington Beach, California, United States, 92648

Contacts

Principal Investigator:

Paul D. Rosenblit

University of Calif Irvine Med Cntr

Recruiting

Irvine, California, United States, 92660

Contacts

Principal Investigator:

Ailin Barseghian El-Farra

Memorial Care Health System

Recruiting

Long Beach, California, United States, 90806

Contacts

Principal Investigator:

Ron Sklash

Keck Medical Center USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Parveen Garg

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Abha Khandelwal

University of California San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Michael John Wilkinson

UCSF

Recruiting

San Francisco, California, United States, 94115

Contacts

Principal Investigator:

Eveline O Stock

Manshadi Heart Institute

Recruiting

Stockton, California, United States, 95204

Contacts

Delaina Sanguinetti

d.sanguinetti@drmanshadi.com

Principal Investigator:

Ramin Manshadi

Univ Of Color Anschutz Med Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

David Saxon

Bridgeport Hospital

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Principal Investigator:

Adam Schussheim

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Principal Investigator:

Antonio Fernandez

Chase Medical Research LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Principal Investigator:

Ashish Adlakha

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Principal Investigator:

Rasha Youssef

Bay Area Cardiology Assoc

Recruiting

Brandon, Florida, United States, 33511

Contacts

Principal Investigator:

Ranchhod Khant

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Principal Investigator:

Michael J Koren

Advanced Research for Health Improvement LLC

Recruiting

Naples, Florida, United States, 34102

Contacts

Principal Investigator:

Julian Javier

Peace River Cardiovascular Center

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

Principal Investigator:

David Allan Hotchkiss

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Principal Investigator:

Alexander J White

East Coast Inst for Research LLC

Recruiting

Saint Augustine, Florida, United States, 32086

Contacts

Principal Investigator:

Ferris George

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Contacts

Principal Investigator:

Neerav Suresh Shah

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Arshed Quyyumi

Cardiovascular Consultants of S GA

Recruiting

Thomasville, Georgia, United States, 31792

Contacts

Principal Investigator:

Christopher Daniels

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Annabelle Volgman

Advocate Lutheran General Childrens Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Principal Investigator:

Adib Chaus

Krannert Institute of Cardiology

Recruiting

Indianapolis, Indiana, United States, 46202-4800

Contacts

Principal Investigator:

Julie Clary

University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Patrick M Moriarty

Cotton O Neil Clinical Res Center

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Principal Investigator:

Michael Cox

Louisiana Heart Center Research

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Principal Investigator:

Frank Voelker

Louisiana Heart Center Research

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Principal Investigator:

Bruce J Iteld

CV Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Contacts

Principal Investigator:

Peter Fail

Omega Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Principal Investigator:

Tuan-Huy Tran

Tulane Center for Clinical Research

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Keith C Ferdinand

CV Ins of the South

Recruiting

Opelousas, Louisiana, United States, 70570

Contacts

Principal Investigator:

Siby George Ayalloore

Louisiana Heart Center Research

Recruiting

Slidell, Louisiana, United States, 70458

Contacts

Principal Investigator:

Marc Bernstein

Maine Health Cardiology

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Edward Teufel

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Alex Gyftopoulos

Sinai Ct for Throm Res and Drug Dev

Recruiting

Baltimore, Maryland, United States, 21209

Contacts

Principal Investigator:

Paul Gurbel

Johns Hopkins Univ School of Med

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Christine McLeod

cmcleod3@jhmi.edu

Principal Investigator:

Thorsten Leucker

Johns Hopkins University

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Tanya Burley

tburley1@jhmi.edu

Principal Investigator:

Daniel Kim

Anderson Medical Research

Recruiting

Ft. Washington, Maryland, United States, 20744

Contacts

Principal Investigator:

Felton Anderson

Adventist HealthCare Shady Grove Medical Center

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Principal Investigator:

Michael Chen

MGH

Recruiting

Boston, Massachusetts, United States, 02114-2696

Contacts

Principal Investigator:

Maria T Vivaldi

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Khaled Abdul-Nour

AA Medical Research Center

Recruiting

Flint, Michigan, United States, 48504

Contacts

Principal Investigator:

Ahmed A Arif

Metro Health Univ of MI Health

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Principal Investigator:

Rony Gorges

Belzoni Clinical Research

Recruiting

Belzoni, Mississippi, United States, 39038

Contacts

Principal Investigator:

Sidney Carlton Gorton

Stern Cardiovascular Foundation Inc

Recruiting

Southaven, Mississippi, United States, 38671

Contacts

Principal Investigator:

Dharmesh Patel

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Contacts

Principal Investigator:

Timothy Smith

Washington Univ School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Anne Goldberg

Mercy Hospital St Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Principal Investigator:

Bruce Czarnik

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Jonathan C Waltman

The Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Principal Investigator:

Joel Landzberg

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Principal Investigator:

Robert Fishberg

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Principal Investigator:

Bani Azari

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Principal Investigator:

Samuel Kim

Icahn School of Med at Mt Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Robert Rosenson

Lenox Hill Hospital

Recruiting

New York, New York, United States, 43210

Contacts

Principal Investigator:

Eugenia Gianos

Northwell Health Physician Peconic

Recruiting

Riverhead, New York, United States, 11901

Contacts

Principal Investigator:

Sean Donahoe

Novant Health Heart Vas Inst

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Anish Vani

Medication Management LLC

Recruiting

Greensboro, North Carolina, United States, 27405

Contacts

Principal Investigator:

James Franklin

Accellacare US Inc

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Principal Investigator:

John Rubino

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Herman Barrett Cheek

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Michael Shapiro

Akron Hospital Summa Health System

Recruiting

Akron, Ohio, United States, 44309

Contacts

Principal Investigator:

Kevin Silver

Aultman Hospital

Recruiting

Canton, Ohio, United States, 44710

Contacts

Principal Investigator:

Ramana Podugu

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Dennis C. Bruemmer

Rama Research LLC

Recruiting

Marion, Ohio, United States, 43302

Contacts

Principal Investigator:

Bhola Rama

Lancaster General Health

Recruiting

Lancaster, Pennsylvania, United States, 17603

Contacts

Principal Investigator:

Marjan U Mujib

Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Archna Bajaj

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Principal Investigator:

Indu Poornima

The Stern Cardiovascular Foundation

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Frank Augustus McGrew

Apex Cardiology Research Associates of Jackson

Recruiting

Jackson, Tennessee, United States, 38301

Contacts

Principal Investigator:

Mohsin Alhaddad

Vanderbilt Univ Medi Cen

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

MacRae Linton

Cardiovascular Res of Knoxville LLC

Recruiting

Powell, Tennessee, United States, 37849

Contacts

Principal Investigator:

Charles B Treasure

Soltero Cardiovascular Research Center

Recruiting

Dallas, Texas, United States, 75226

Contacts

Principal Investigator:

Cara East

North Texas Endocrine Center

Recruiting

Dallas, Texas, United States, 75231

Contacts

Principal Investigator:

Peter Bressler

SW Family Medicine Associates

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Chrisette Dharma

Baylor College Of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Christie M Ballantyne

Grace Research

Recruiting

Marshall, Texas, United States, 75670

Contacts

Principal Investigator:

William Eaves

Northwest Houston Clinical Research PLLC

Recruiting

Tomball, Texas, United States, 77375

Contacts

Principal Investigator:

Shamaila Aslam

Progressive Clinical Research

Recruiting

Bountiful, Utah, United States, 84010

Contacts

Principal Investigator:

Joshua Oaks

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

Jeffrey Anderson

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132-0001

Contacts

Principal Investigator:

Aaron Shoskes

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Jared Spitz

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Tariq Haddad

Carient Heart and Vascular

Recruiting

Manassas, Virginia, United States, 20109

Contacts

Principal Investigator:

Vikram Prasanna

Dominion Medical Associates

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Principal Investigator:

Richard A Jackson

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Francis Kim

Swedish Medical Center-Cardiovascular Research

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

John Petersen II

Univ of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Kelley Branch

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Sudarshan Balla

St Luke s Medical Center Aurora

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Jayant Khitha

Novartis Investigative Site

Recruiting

Vancouver, British Columbia, Canada, V6Z 2H2

Novartis Investigative Site

Recruiting

Victoria, British Columbia, Canada, V8R4R2

Novartis Investigative Site

Recruiting

Victoria, British Columbia, Canada, V8T 5G4

Novartis Investigative Site

Recruiting

Oakville, Ontario, Canada, L6K 3W7

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M9V 4B4

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Lipoprotein(a),
  • Lp(a),
  • cardiovascular disease,
  • CVD,
  • myocardial infarction,
  • stroke,
  • OLE,
  • pelacarsen,
  • open-label

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-04.