Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
NCT ID: NCT06267560
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
422 participants
INTERVENTIONAL
2024-04-24
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQJ230
TQJ230 80mg QM s.c.
TQJ230
TQJ230 80mg QM s.c.
Placebo
Matching placebo.
Placebo
matching placebo
Interventions
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TQJ230
TQJ230 80mg QM s.c.
Placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 pressure and 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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National Heart Institute
Beverly Hills, California, United States
Alliance Clinical
Canoga Park, California, United States
Parkway Medical Center
Birmingham, Alabama, United States
Synexus
Glendale, Arizona, United States
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, United States
Valley Clinical Trials Inc
Covina, California, United States
NICRs Research Center
Garden Grove, California, United States
University of Calif Irvine Med Cntr
Irvine, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Angel City Research Inc
Los Angeles, California, United States
Velocity Clinical Trials
Los Angeles, California, United States
California Medical Research Associates Inc
Northridge, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Acclaim Clinical Research
San Diego, California, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
C and A Clinical Trials
Cape Coral, Florida, United States
Proactive Clinical Research
Fort Lauderdale, Florida, United States
National Research Institute
Hialeah, Florida, United States
Sister Life Research Inc
Hialeah, Florida, United States
Zenith Clinical Research
Hollywood, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Infinite Clinical Research
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Baptist Health Medical Group
Miami, Florida, United States
A&A Research Group Inc
Miami, Florida, United States
Clinical Site Partners LLC dba Flourish Research
Miami, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Eminat LLC
Miramar, Florida, United States
CTMD Research
Palm Springs, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
New Tampa Health
Tampa, Florida, United States
James A Haley Veterans Hospital
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Morehouse School Of Medicine
Atlanta, Georgia, United States
Comprehensive Neurosciences Inc
Atlanta, Georgia, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, United States
Synexus Clinical Research US Inc
Chicago, Illinois, United States
Chicago Clinical Research Inst
Chicago, Illinois, United States
Flourish Research
Grandwood Park, Illinois, United States
Cardiovascular Associates Research
Covington, Louisiana, United States
Omega Clinical Research
Metairie, Louisiana, United States
CV Ins of the South
Opelousas, Louisiana, United States
Monroe Research Llc
West Monroe, Louisiana, United States
Southern Clin Research Clinic
Zachary, Louisiana, United States
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, United States
Johns Hopkins Univ School of Med
Baltimore, Maryland, United States
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, United States
Johns Hopkins University
Columbia, Maryland, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Capitol Cardiology Associates
Lanham, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Aa Mrc Mhs
Flint, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
Elite Clinical Research LLC
Jackson, Mississippi, United States
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, United States
Las Vegas Endocrinology
Henderson, Nevada, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Alliance Medical Ministry
Raleigh, North Carolina, United States
Velocity Clin Research Springdale
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
NexGen Research
Lima, Ohio, United States
Care Access Research
Easton, Pennsylvania, United States
TCV Clinical Studies
Linwood, Pennsylvania, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, United States
Plano Primary Care Clinic
Allen, Texas, United States
Pharma Tex Research
Amarillo, Texas, United States
North Hills Medical Research Inc
Bedford, Texas, United States
SW Family Medicine Associates
Dallas, Texas, United States
David Turbay MD PLLC
El Paso, Texas, United States
Ctr for Clin Rsch and Innovatn
Houston, Texas, United States
Angiocardiac Care of Texas PA
Houston, Texas, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
The Heart Institute of East Texas
Lufkin, Texas, United States
Discovery Clinical Trials
Pflugerville, Texas, United States
University of Texas Health Science Ctr
San Antonio, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Sugar Lakes Family Practice
Sugar Land, Texas, United States
Javara Research
Alexandria, Virginia, United States
Virginia Heart
Falls Church, Virginia, United States
Heart Care Associates P C
Hopewell, Virginia, United States
Dominion Medical Associates
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
Dr Yolanda Figueroa Private Pr
Humacao, , Puerto Rico
CAIMED Center
Ponce, , Puerto Rico
Research and Cardiovascular Corp
Ponce, , Puerto Rico
Latin Clinical Trial Center Inc
San Juan, , Puerto Rico
VA Caribbean Healthcare System
San Juan, , Puerto Rico
Advanced Medical Research Center
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CTQJ230A12303
Identifier Type: -
Identifier Source: org_study_id