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

Last updated: March 18, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Atherosclerosis

Vascular Diseases

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 11, 2027

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

    Active - Recruiting

  • Dr Yolanda Figueroa Private Pr

    Humacao, 00791
    Puerto Rico

    Active - Recruiting

  • CAIMED Center

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Research and Cardiovascular Corp

    Ponce, 00717-1322
    Puerto Rico

    Active - Recruiting

  • Advanced Medical Research Center

    San Juan, 00926
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center Inc

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • VA Caribbean Healthcare System

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Parkway Medical Center

    Birmingham, Alabama 35215
    United States

    Active - Recruiting

  • Synexus Clinical Research Advantage

    Birmingham, Alabama 35211
    United States

    Active - Recruiting

  • Optimal Research LLC

    Huntsville, Alabama 35802
    United States

    Active - Recruiting

  • Synexus

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Cardiology and Medicine Clinic PA

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • Cardiology and Medicine Clinic, PA

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • National Heart Institute

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Valley Clinical Trials Inc

    Covina, California 91723
    United States

    Active - Recruiting

  • NICRs Research Center

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Long Beach Clinical Trials

    Long Beach, California 90806
    United States

    Active - Recruiting

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Angel City Research Inc

    Los Angeles, California 90026
    United States

    Active - Recruiting

  • Velocity Clinical Trials

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Active - Recruiting

  • Ventura Heart Institute

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • C and A Clinical Trials

    Cape Coral, Florida 33990
    United States

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  • Proactive Clinical Research

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • National Research Institute

    Hialeah, Florida 33013
    United States

    Active - Recruiting

  • Sister Life Research Inc

    Hialeah, Florida 33013
    United States

    Active - Recruiting

  • Zenith Clinical Research

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Baptist Health Medical Group

    Miami, Florida 33173
    United States

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  • Clinical Trials of Florida

    Miami, Florida 33186
    United States

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  • Columbus Clinical Services LLC

    Miami, Florida 33125
    United States

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  • Finlay Medical Research

    Miami, Florida 33126
    United States

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  • International Research Associates, LLC

    Miami, Florida 33156
    United States

    Active - Recruiting

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Eminat LLC

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • CTMD Research

    Palm Springs, Florida 33406
    United States

    Active - Recruiting

  • DBC Research USA

    Pembroke Pines, Florida 33029
    United States

    Active - Recruiting

  • Fam Medical Specialists Of Fl Plc

    Plant City, Florida 33563
    United States

    Active - Recruiting

  • TBC Research LLC

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • James A Haley Veterans Hospital

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • New Tampa Health

    Tampa, Florida 33603
    United States

    Active - Recruiting

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida 33449
    United States

    Active - Recruiting

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Morehouse School Of Medicine

    Atlanta, Georgia 30310
    United States

    Active - Recruiting

  • Atlanta Heart Specialists LLC

    Tucker, Georgia 30084
    United States

    Active - Recruiting

  • Chicago Clinical Research Inst

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Flourish Research

    Grandwood Park, Illinois 60031
    United States

    Active - Recruiting

  • Cambridge Medical Trials

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Cambridge Medical Trials .

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Cardiovascular Associates Research

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Omega Clinical Research

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • CV Ins of the South

    Opelousas, Louisiana 70570
    United States

    Active - Recruiting

  • Southern Clin Research Clinic

    Zachary, Louisiana 70791
    United States

    Active - Recruiting

  • Southern Clinical Research Clinic .

    Zachary, Louisiana 70791
    United States

    Active - Recruiting

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Johns Hopkins Univ School of Med

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Sinai Ct for Throm Res and Drug Dev

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Metropolitan Cardiovascular Consultants Llc

    Beltsville, Maryland 20705
    United States

    Active - Recruiting

  • Johns Hopkins University

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Anderson Medical Research

    Fort Washington, Maryland 20744
    United States

    Active - Recruiting

  • Capitol Cardiology Associates

    Lanham, Maryland 20706
    United States

    Active - Recruiting

  • MD Medical Research

    Oxon Hill, Maryland 20745
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Aa Mrc Llc

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Flint Clinical Research

    Flint, Michigan 48503
    United States

    Active - Recruiting

  • Elite Clinical Research LLC

    Jackson, Mississippi 39211
    United States

    Active - Recruiting

  • Stern Cardiovascular Foundation Inc

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • Las Vegas Endocrinology

    Henderson, Nevada 89074
    United States

    Active - Recruiting

  • AB Clinical Trials

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Clinical Research of South Nevada

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • University At Buffalo

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Jamaica Hospital Medical Center

    Jamaica, New York 11418
    United States

    Active - Recruiting

  • Mid Hudson Medical Research PLLC

    New Windsor, New York 12553
    United States

    Active - Recruiting

  • Wake Forest Health Network LLC

    Asheboro, North Carolina 27203
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Velocity Clin Research Springdale

    Cincinnati, Ohio 45246
    United States

    Active - Recruiting

  • Hometown Urgent Care and Research

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • NexGen Research

    Lima, Ohio 45801
    United States

    Active - Recruiting

  • Care Access Research

    Easton, Pennsylvania 18045
    United States

    Active - Recruiting

  • TCV Clinical Studies

    Linwood, Pennsylvania 19061
    United States

    Active - Recruiting

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Apex Cardiology Research Associates of Jackson

    Jackson, Tennessee 38301
    United States

    Active - Recruiting

  • Plano Primary Care Clinic

    Allen, Texas 75002-3688
    United States

    Active - Recruiting

  • Pharma Tex Research

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • North Hills Medical Research Inc

    Bedford, Texas 76021
    United States

    Active - Recruiting

  • North Hills Medical Research, Inc .

    Bedford, Texas 76021
    United States

    Active - Recruiting

  • SW Family Medicine Associates

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • David Turbay MD PLLC

    El Paso, Texas 79905
    United States

    Active - Recruiting

  • Angiocardiac Care of Texas PA

    Houston, Texas 77025
    United States

    Active - Recruiting

  • Biopharma Informatic LLC

    Houston, Texas 77084
    United States

    Active - Recruiting

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Active - Recruiting

  • Discovery Clinical Trials

    Pflugerville, Texas 78660-3015
    United States

    Active - Recruiting

  • Clinical Trials of Texas

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Clinical Trials of Texas .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Javara Research

    San Marcos, Texas 78666
    United States

    Active - Recruiting

  • Ctr For Clin Rsrch And Innovation

    Spring, Texas 77389
    United States

    Active - Recruiting

  • Ctr For Clin Rsrch And Innovation Research

    Spring, Texas 77389
    United States

    Active - Recruiting

  • Sugar Lakes Family Practice

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Javara Research

    Alexandria, Virginia 22311
    United States

    Active - Recruiting

  • Virginia Heart

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Heart Care Associates P C

    Hopewell, Virginia 23860
    United States

    Active - Recruiting

  • Dominion Medical Associates

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298-0111
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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