Recruiting

Phase 2

PelacarsenA Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05646381

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Pelacarsen (TQJ230) 80mg

Matching placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Conditions

Aortic Stenosis

Study ID

NCT05646381

Start date

Mar 7, 2024

Status verified date

Jun, 2026

Completion date

Mar 12, 2030

Anticipated

Primary completion date

Mar 12, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male and female ≥50 to <80 years of age at Screening Part II
Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
Mild or moderate calcific aortic valve stenosis
At the randomization visit, participant must be optimally treated for existing CV risk factors

Exclusion Criteria:

Severe calcific aortic valve stenosis
Uncontrolled hypertension
History of malignancy of any organ system
History of hemorrhagic stroke or other major bleeding
Platelet count ≤ LLN
Active liver disease or hepatic dysfunction
Significant kidney disease
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Enrollment

502 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pelacarsen (TQJ230) 80mg

Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously

placebo comparator: Matching placebo

Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

Interventions

Pelacarsen (TQJ230) 80mg

Matching placebo

Primary outcome measure

Change in peak aortic jet velocity [ Time Frame: 36 months ]
Change in aortic valve calcium score [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Heart Center Research Llc

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Amy Williams

+1 256 519 8255 awilliams@theheartcenter.md

Principal Investigator:

Vernon R Hunter

Cardiovascular Res Found

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Juan Ramos

+1 310 278 3400 juan.ramos@cvmg.com

Principal Investigator:

Ronald P Karlsberg

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Maria Flores

+1 301 289 5221 mflores@nationalheartinstitute.org

Principal Investigator:

Norman Lepor

Flourish Clinical Resrch Covin

Recruiting

Covina, California, United States, 91723

Contacts

Sarita Garcia

+1 714 299 2412 sgarcia@flourishresearch.com

Principal Investigator:

Fahed Bitar

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

Contacts

Haydee Gutierrez

+1 818 280 4220 haydee@valleyclinicaltrials.com

Principal Investigator:

Mehrdad Ariani

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Tamara Bazouzi

+1 650 736 7878 bazouzit@stanford.edu

Principal Investigator:

Abha Khandelwal

University Of California San Diego

Recruiting

San Diego, California, United States, 92103-8415

Contacts

Ruby Swaim

+1 858 246 2510 rswaim@health.ucsd.edu

Principal Investigator:

Anna Narezkina

UC San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Liliann Zou

+1 415 514 3156 liliann.zou@ucsf.edu

Principal Investigator:

Eveline Stock

Nova Clinical Research LLC

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Sade Andrews

+1 941 792 6564 sade.andrews@novaclinicalresearch.com

Principal Investigator:

Christian Zellner

Flourish Res Acq LLC North Miami

Recruiting

Miami, Florida, United States, 33138

Contacts

Ashlee Sealy

asealy@flourishresearch.com

Principal Investigator:

Rimsky Denis

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Dora Gutierrez

+1 786 502 4303 dgutierrez@inpatientresearch.com

Principal Investigator:

Alexis Gutierrez

Midwest Heart and Vascular Spec

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Elizabeth Fulks

+1 913 253 3000 Elizabeth.fulks@hcahealthcare.com

Principal Investigator:

Vasvi Singh

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Veronique Recile

+1 617 636 5897

Principal Investigator:

Benjamin Wessler

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria Viscosi

+1 813 943 3440 vviscosi@mgh.harvard.edu

Principal Investigator:

Michael Honigberg

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria Viscosi

vviscosi@mgh.harvard.edu

Principal Investigator:

Michael Honigberg

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sam Wong

+1 617 347 8680 swong1@bwh.harvard.edu

Principal Investigator:

Rhanderson Cardoso

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sam Wong

+1 617 525 1227 swong1@bwh.harvard.edu

Principal Investigator:

Rhanderson Cardoso

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jodi Carter, BS, CCRP

+1 (313) 916-3613

Principal Investigator:

Khaled Abdul-Nour

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jodi Carter

+1 313 590 2407 jcarte23@hfhs.org

Principal Investigator:

Khaled Abdul-Nour

AA Medical Research Center

Recruiting

Flint, Michigan, United States, 48504

Contacts

Fayyaz Shah

+1 810 237 1125 fshah@aamrc.net

Principal Investigator:

Ahmed A Arif

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073-4192

Contacts

Rachel Wylie

+1 248 551 4192 rachel.wylie@corewellhealth.org

Principal Investigator:

Joel Skaistis

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Michelle Pitt

+1 612 624 4948 henni032@umn.edu

Principal Investigator:

Daniel Duprez

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Rosmery Montesino

+1 908 522 6279 Rosmery.montesino@atlantichealth.org

Principal Investigator:

Robert Fishberg

Capital Cardiology Associates

Recruiting

Albany, New York, United States, 12211

Contacts

Shreya Shah

sshah@capitalcardiology.com

Principal Investigator:

Lance Sullenberger

Icahn School of Med at Mt Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jay Krishna Katragadda

+1 212 659 9174 jaykrishna.katragadda@mssm.edu

Principal Investigator:

Robert Rosenson

Strong Memorial Hospital

Recruiting

Rochester, New York, United States, 14642

Contacts

Ferogh Shakouri

+1 716 275 7753 ferogh_shakouri@URMC.Rochester.edu

Principal Investigator:

Robert Block

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Donna Davis

donna.h.davis@advocatehealth.org

Principal Investigator:

Michael Shapiro

Lindner Ctr At The Christ Hosp

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Meghan Grone

+1 513 585 1777 Meghan.Grone@thechristhospital.com

Principal Investigator:

Sitaramesh Emani

Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Manali Shah

manali.shah2@pennmedicine.upenn.edu

Principal Investigator:

Archna Bajaj

Texas Heart Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Dominique Robertson

+1 832 355 8520 dominique.robertson@bcm.edu

Principal Investigator:

Alexander Postalian

Orion Medical

Recruiting

Houston, Texas, United States, 77034

Contacts

Lena Olivera Perez

lena.oliveraperez@usheartandvascular.com

Principal Investigator:

Karan Bhalla

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Oyinda Agbale

+1 703 766 5920 oagbale@virginiaheart.com

Principal Investigator:

Tariq Haddad

Carient Heart and Vascular

Recruiting

Manassas, Virginia, United States, 20109

Contacts

Hameeda Tasneem

+1 70 333 58 750 htasneem@carient.com

Principal Investigator:

Vikram Prasanna

Novartis Investigative Site

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Novartis Investigative Site

Recruiting

North York, Ontario, Canada, M6B 3H7

Novartis Investigative Site

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

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, G1V 4G5

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

Cardiovascular
Lipoprotein(a)
Lp(a)
Hyperlipoproteinemia(a)
Calcific aortic valve stenosis
TQJ230
Pelacarsen
Aortic valve stenosis
Aortic stenosis

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 2026-06-23.