Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Last updated: July 10, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Vascular Diseases

Atherosclerosis

Treatment

Placebo

TQJ230

Clinical Study ID

NCT06267560
CTQJ230A12303
  • Ages 18-80
  • All Genders

Study Summary

Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female US Black/African American and US Hispanic participants 18 to ≤ 80years of age

  • Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory

  • On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressureand diabetes, at the randomization visit according to local practice/guidelines.

  • Established ASCVD disease defined as documented:

  • Coronary heart disease (CHD) and/or

  • Cerebrovascular disease (CVD) and/or

  • Peripheral arterial disease (PAD):

Exclusion

Exclusion Criteria:

  • Uncontrolled hypertension

  • Heart failure New York Heart Association (NYHA) class IV

  • History of malignancy of any organ system

  • History of hemorrhagic stroke or other major bleeding

  • Platelet count <140,000 per mm3

  • Active liver disease or hepatic dysfunction

  • Significant kidney disease

  • Pregnant or nursing women

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 24, 2024
Estimated Completion Date:
March 31, 2026

Study Description

CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).

Connect with a study center

  • Advanced Clinical Research LLC

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Dr Yolanda Figueroa Private Pr

    Humacao, 00791
    Puerto Rico

    Site Not Available

  • CAIMED Center

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Research and Cardiovascular Corp

    Ponce, 00717-1322
    Puerto Rico

    Site Not Available

  • Advanced Medical Research Center

    San Juan, 00926
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center Inc

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • VA Caribbean Healthcare System

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Central Alabama Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Parkway Medical Center

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Synexus Clinical Research Advantage

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • Optimal Research LLC

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Synexus

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Cardiology and Medicine Clinic PA

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Cardiology and Medicine Clinic, PA

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • National Heart Institute

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Hope Clinical Research

    Canoga Park, California 91303
    United States

    Site Not Available

  • Valley Clinical Trials Inc

    Covina, California 91723
    United States

    Site Not Available

  • NICRs Research Center

    Garden Grove, California 92844
    United States

    Site Not Available

  • University of Calif Irvine Med Cntr

    Irvine, California 92660
    United States

    Site Not Available

  • Long Beach Clinical Trials

    Long Beach, California 90806
    United States

    Site Not Available

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Site Not Available

  • Angel City Research Inc

    Los Angeles, California 90026
    United States

    Site Not Available

  • Velocity Clinical Trials

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • California Medical Research Associates Inc

    Northridge, California 91324
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Completed

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Ventura Heart Institute

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Howard University School of Med

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • C and A Clinical Trials

    Cape Coral, Florida 33990
    United States

    Site Not Available

  • Proactive Clinical Research

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • National Research Institute

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Sister Life Research Inc

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Zenith Clinical Research

    Hollywood, Florida 33021
    United States

    Site Not Available

  • A&A Research Group Inc

    Miami, Florida 33186
    United States

    Site Not Available

  • Baptist Health Medical Group

    Miami, Florida 33173
    United States

    Site Not Available

  • Clinical Trials of Florida

    Miami, Florida 33186
    United States

    Site Not Available

  • Columbus Clinical Services LLC

    Miami, Florida 33125
    United States

    Site Not Available

  • Finlay Medical Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Infinite Clinical Research

    Miami, Florida 33133
    United States

    Site Not Available

  • International Research Associates, LLC

    Miami, Florida 33156
    United States

    Site Not Available

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Eminat LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • CTMD Research

    Palm Springs, Florida 33406
    United States

    Site Not Available

  • DBC Research USA

    Pembroke Pines, Florida 33029
    United States

    Site Not Available

  • Fam Medical Specialists Of Fl Plc

    Plant City, Florida 33563
    United States

    Site Not Available

  • TBC Research LLC

    Tamarac, Florida 33321
    United States

    Site Not Available

  • James A Haley Veterans Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • New Tampa Health

    Tampa, Florida 33603
    United States

    Site Not Available

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida 33449
    United States

    Site Not Available

  • Comprehensive Neurosciences Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Morehouse School Of Medicine

    Atlanta, Georgia 30310
    United States

    Site Not Available

  • Atlanta Heart Specialists LLC

    Tucker, Georgia 30084
    United States

    Site Not Available

  • Chicago Clinical Research Inst

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Flourish Research

    Grandwood Park, Illinois 60031
    United States

    Site Not Available

  • Cambridge Medical Trials

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Cambridge Medical Trials .

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Christus Health Central Louisiana

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Cardiovascular Associates Research

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Omega Clinical Research

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Tulane Uni Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • CV Ins of the South

    Opelousas, Louisiana 70570
    United States

    Site Not Available

  • Monroe Research Llc

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Southern Clin Research Clinic

    Zachary, Louisiana 70791
    United States

    Site Not Available

  • Southern Clinical Research Clinic .

    Zachary, Louisiana 70791
    United States

    Active - Recruiting

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Johns Hopkins Univ School of Med

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Sinai Ct for Throm Res and Drug Dev

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Metropolitan Cardiovascular Consultants Llc

    Beltsville, Maryland 20705
    United States

    Site Not Available

  • Johns Hopkins University

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Anderson Medical Research

    Fort Washington, Maryland 20744
    United States

    Site Not Available

  • Capitol Cardiology Associates

    Lanham, Maryland 20706
    United States

    Site Not Available

  • MD Medical Research

    Oxon Hill, Maryland 20745
    United States

    Site Not Available

  • Adventist HealthCare Shady Grove Medical Center

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Aa Mrc Llc

    Flint, Michigan 48504
    United States

    Site Not Available

  • Flint Clinical Research

    Flint, Michigan 48503
    United States

    Site Not Available

  • Elite Clinical Research LLC

    Jackson, Mississippi 39211
    United States

    Site Not Available

  • University of Mississippi Med Ctr

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Stern Cardiovascular Foundation Inc

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Truman Medical Center

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Las Vegas Endocrinology

    Henderson, Nevada 89074
    United States

    Site Not Available

  • AB Clinical Trials

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Clinical Research of South Nevada

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Clinical Research of South Nevada .

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • University At Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • Jamaica Hospital Medical Center

    Jamaica, New York 11418
    United States

    Site Not Available

  • Mid Hudson Medical Research PLLC

    New Windsor, New York 12553
    United States

    Site Not Available

  • Wake Forest Health Network LLC

    Asheboro, North Carolina 27203
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Alliance Medical Ministry

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Velocity Clin Research Springdale

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • NexGen Research

    Lima, Ohio 45801
    United States

    Site Not Available

  • Care Access Research

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • TCV Clinical Studies

    Linwood, Pennsylvania 19061
    United States

    Site Not Available

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Apex Cardiology Research Associates of Jackson

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • Plano Primary Care Clinic

    Allen, Texas 75002-3688
    United States

    Site Not Available

  • Pharma Tex Research

    Amarillo, Texas 79106
    United States

    Site Not Available

  • North Hills Medical Research Inc

    Bedford, Texas 76021
    United States

    Site Not Available

  • North Hills Medical Research, Inc .

    Bedford, Texas 76021
    United States

    Active - Recruiting

  • SW Family Medicine Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • David Turbay MD PLLC

    El Paso, Texas 79905
    United States

    Site Not Available

  • Vast Clinical Research LLC

    Garland, Texas 75041
    United States

    Site Not Available

  • Angiocardiac Care of Texas PA

    Houston, Texas 77025
    United States

    Site Not Available

  • Biopharma Informatic LLC

    Houston, Texas 77084
    United States

    Site Not Available

  • Ctr for Clin Rsch and Innovatn

    Houston, Texas 77008
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Site Not Available

  • The Heart Institute of East Texas

    Lufkin, Texas 75904
    United States

    Site Not Available

  • CardioVoyage LLC

    McKinney, Texas 75071
    United States

    Site Not Available

  • Discovery Clinical Trials

    Pflugerville, Texas 78660-3015
    United States

    Active - Recruiting

  • Austin Heart PA

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Clinical Trials of Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Texas Health Science Ctr

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • Javara Research

    San Marcos, Texas 78666
    United States

    Site Not Available

  • Ctr For Clin Rsrch And Innovation

    Spring, Texas 77389
    United States

    Site Not Available

  • Ctr For Clin Rsrch And Innovation Research

    Spring, Texas 77389
    United States

    Active - Recruiting

  • Sugar Lakes Family Practice

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Javara Research

    Alexandria, Virginia 22311
    United States

    Site Not Available

  • Virginia Heart

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Heart Care Associates P C

    Hopewell, Virginia 23860
    United States

    Site Not Available

  • Dominion Medical Associates

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298-0111
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

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