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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Keywords

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Elevated Lp(a) Cardiovascular disease Pelacarsen (TQJ230)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months.

Study Groups

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TQJ230

TQJ230 80mg QM s.c.

Group Type EXPERIMENTAL

TQJ230

Intervention Type DRUG

TQJ230 80mg QM s.c.

Placebo

Matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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TQJ230

TQJ230 80mg QM s.c.

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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pelacarsen

Eligibility Criteria

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Inclusion Criteria

* Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years 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 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Alliance Clinical

Canoga Park, California, United States

Site Status

Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Synexus

Glendale, Arizona, United States

Site Status

Cardiology and Medicine Clinic PA

Little Rock, Arkansas, United States

Site Status

Valley Clinical Trials Inc

Covina, California, United States

Site Status

NICRs Research Center

Garden Grove, California, United States

Site Status

University of Calif Irvine Med Cntr

Irvine, California, United States

Site Status

Long Beach Clinical Trials

Long Beach, California, United States

Site Status

Angel City Research Inc

Los Angeles, California, United States

Site Status

Velocity Clinical Trials

Los Angeles, California, United States

Site Status

California Medical Research Associates Inc

Northridge, California, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

Site Status

Acclaim Clinical Research

San Diego, California, United States

Site Status

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States

Site Status

C and A Clinical Trials

Cape Coral, Florida, United States

Site Status

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Site Status

National Research Institute

Hialeah, Florida, United States

Site Status

Sister Life Research Inc

Hialeah, Florida, United States

Site Status

Zenith Clinical Research

Hollywood, Florida, United States

Site Status

Columbus Clinical Services LLC

Miami, Florida, United States

Site Status

Finlay Medical Research

Miami, Florida, United States

Site Status

Infinite Clinical Research

Miami, Florida, United States

Site Status

International Research Associates, LLC

Miami, Florida, United States

Site Status

Baptist Health Medical Group

Miami, Florida, United States

Site Status

A&A Research Group Inc

Miami, Florida, United States

Site Status

Clinical Site Partners LLC dba Flourish Research

Miami, Florida, United States

Site Status

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Site Status

Eminat LLC

Miramar, Florida, United States

Site Status

CTMD Research

Palm Springs, Florida, United States

Site Status

DBC Research USA

Pembroke Pines, Florida, United States

Site Status

New Tampa Health

Tampa, Florida, United States

Site Status

James A Haley Veterans Hospital

Tampa, Florida, United States

Site Status

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Site Status

Grady Health System

Atlanta, Georgia, United States

Site Status

Morehouse School Of Medicine

Atlanta, Georgia, United States

Site Status

Comprehensive Neurosciences Inc

Atlanta, Georgia, United States

Site Status

Atlanta Heart Specialists LLC

Tucker, Georgia, United States

Site Status

Synexus Clinical Research US Inc

Chicago, Illinois, United States

Site Status

Chicago Clinical Research Inst

Chicago, Illinois, United States

Site Status

Flourish Research

Grandwood Park, Illinois, United States

Site Status

Cardiovascular Associates Research

Covington, Louisiana, United States

Site Status

Omega Clinical Research

Metairie, Louisiana, United States

Site Status

CV Ins of the South

Opelousas, Louisiana, United States

Site Status

Monroe Research Llc

West Monroe, Louisiana, United States

Site Status

Southern Clin Research Clinic

Zachary, Louisiana, United States

Site Status

Sinai Ct for Throm Res and Drug Dev

Baltimore, Maryland, United States

Site Status

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Site Status

Johns Hopkins Univ School of Med

Baltimore, Maryland, United States

Site Status

Metropolitan Cardiovascular Consultants Llc

Beltsville, Maryland, United States

Site Status

Johns Hopkins University

Columbia, Maryland, United States

Site Status

Anderson Medical Research

Ft. Washington, Maryland, United States

Site Status

Capitol Cardiology Associates

Lanham, Maryland, United States

Site Status

MD Medical Research

Oxon Hill, Maryland, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Aa Mrc Mhs

Flint, Michigan, United States

Site Status

Aa Mrc Llc

Flint, Michigan, United States

Site Status

Elite Clinical Research LLC

Jackson, Mississippi, United States

Site Status

Stern Cardiovascular Foundation Inc

Southaven, Mississippi, United States

Site Status

Las Vegas Endocrinology

Henderson, Nevada, United States

Site Status

AB Clinical Trials

Las Vegas, Nevada, United States

Site Status

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Site Status

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Overlook Medical Center

Summit, New Jersey, United States

Site Status

Jamaica Hospital Medical Center

Jamaica, New York, United States

Site Status

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status

Alliance Medical Ministry

Raleigh, North Carolina, United States

Site Status

Velocity Clin Research Springdale

Cincinnati, Ohio, United States

Site Status

Hometown Urgent Care and Research

Columbus, Ohio, United States

Site Status

NexGen Research

Lima, Ohio, United States

Site Status

Care Access Research

Easton, Pennsylvania, United States

Site Status

TCV Clinical Studies

Linwood, Pennsylvania, United States

Site Status

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Site Status

Apex Cardiology Research Associates of Jackson

Jackson, Tennessee, United States

Site Status

Plano Primary Care Clinic

Allen, Texas, United States

Site Status

Pharma Tex Research

Amarillo, Texas, United States

Site Status

North Hills Medical Research Inc

Bedford, Texas, United States

Site Status

SW Family Medicine Associates

Dallas, Texas, United States

Site Status

David Turbay MD PLLC

El Paso, Texas, United States

Site Status

Ctr for Clin Rsch and Innovatn

Houston, Texas, United States

Site Status

Angiocardiac Care of Texas PA

Houston, Texas, United States

Site Status

Dallas Heart and Vascular Consultants PA

Houston, Texas, United States

Site Status

Epic Clinical Research

Lewisville, Texas, United States

Site Status

The Heart Institute of East Texas

Lufkin, Texas, United States

Site Status

Discovery Clinical Trials

Pflugerville, Texas, United States

Site Status

University of Texas Health Science Ctr

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status

Sugar Lakes Family Practice

Sugar Land, Texas, United States

Site Status

Javara Research

Alexandria, Virginia, United States

Site Status

Virginia Heart

Falls Church, Virginia, United States

Site Status

Heart Care Associates P C

Hopewell, Virginia, United States

Site Status

Dominion Medical Associates

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Advanced Clinical Research LLC

Bayamón, , Puerto Rico

Site Status

Dr Yolanda Figueroa Private Pr

Humacao, , Puerto Rico

Site Status

CAIMED Center

Ponce, , Puerto Rico

Site Status

Research and Cardiovascular Corp

Ponce, , Puerto Rico

Site Status

Latin Clinical Trial Center Inc

San Juan, , Puerto Rico

Site Status

VA Caribbean Healthcare System

San Juan, , Puerto Rico

Site Status

Advanced Medical Research Center

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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CTQJ230A12303

Identifier Type: -

Identifier Source: org_study_id