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

May 18, 2026 updated by: Novartis Pharmaceuticals

A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research LLC
      • Humacao, Puerto Rico, 00791
        • Dr Yolanda Figueroa Private Pr
      • Ponce, Puerto Rico, 00717-1322
        • Research and Cardiovascular Corp
      • Ponce, Puerto Rico, 00716
        • CAIMED Center
      • San Juan, Puerto Rico, 00926
        • Advance Medical Research Center
      • San Juan, Puerto Rico, 00921
        • VA Caribbean Healthcare System
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Cardiology and Medicine Clinic PA
    • California
      • Beverly Hills, California, United States, 90211
        • National Heart Institute
      • Canoga Park, California, United States, 91303
        • Alliance Clinical
      • Covina, California, United States, 91723
        • Valley Clinical Trials Inc
      • Garden Grove, California, United States, 92844
        • NICRs Research Center
      • Irvine, California, United States, 92660
        • University of Calif Irvine Med Cntr
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials
      • Los Angeles, California, United States, 90026
        • Angel City Research Inc
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials LLC
      • Cape Coral, Florida, United States, 33990
        • C and A Clinical Trials
      • Fort Lauderdale, Florida, United States, 33308
        • Proactive Clinical Research
      • Hialeah, Florida, United States, 33013
        • National Research Institute
      • Hialeah, Florida, United States, 33013
        • Sister Life Research Inc
      • Hollywood, Florida, United States, 33021
        • Zenith clinical research
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33133
        • Infinite Clinical Research
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services LLC
      • Miami, Florida, United States, 33156
        • International Research Associates, LLC
      • Miami, Florida, United States, 33186
        • A&A Research Group Inc
      • Miami, Florida, United States, 33135
        • Flourish Research Miami LLC.
      • Miami, Florida, United States, 33173
        • Baptist Health South
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinical LLC
      • Miramar, Florida, United States, 33027
        • FXM Clin Res Miramar LLC
      • Palm Springs, Florida, United States, 33406
        • CTMD Research
      • Pembroke Pines, Florida, United States, 33029
        • DBC Research USA
      • Tampa, Florida, United States, 33603
        • New Tampa Health
      • Tampa, Florida, United States, 33612
        • James A Haley Veterans Hospital
      • Wellington, Florida, United States, 33449
        • Cardiology Partners Clinical Research Institute
      • Winter Park, Florida, United States, 32789
        • Flourish Research
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
      • Tucker, Georgia, United States, 30084
        • Atlanta Heart Specialists LLC
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Synexus Clinical Research US Inc
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Inst
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Cardiovascular Associates Research
      • Metairie, Louisiana, United States, 70006
        • Omega Clinical Research
      • Opelousas, Louisiana, United States, 70570
        • CV Ins of the South
      • West Monroe, Louisiana, United States, 71291
        • Monroe Research LLC
      • Zachary, Louisiana, United States, 70791
        • Southern Clin Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Ascension Saint Agnes Heart Care
      • Baltimore, Maryland, United States, 21209
        • Sinai Ct for Throm Res and Drug Dev
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Univ School of Med
      • Beltsville, Maryland, United States, 20705
        • Metropolitan Cardiovascular Consultants LLC
      • Columbia, Maryland, United States, 21044
        • Johns Hopkins University
      • Ft. Washington, Maryland, United States, 20744
        • Anderson Medical Research
      • Lanham, Maryland, United States, 20706
        • Capitol Cardiology Associates
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Flint, Michigan, United States, 48504
        • Aa Mrc Llc
      • Flint, Michigan, United States, 48503
        • Aa Mrc Mhs
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Elite Clinical Research LLC
      • Southaven, Mississippi, United States, 38671
        • Stern Cardiovascular Foundation Inc
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Las Vegas Endocrinology
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • New York
      • Richmond Hill, New York, United States, 11418
        • Jamaica Hospital Medical Center
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Raleigh, North Carolina, United States, 27610
        • Alliance Medical Ministry
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Velocity Clin Research Springdale
      • Lima, Ohio, United States, 45801
        • Nexgen Research
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Care Access Research
      • Linwood, Pennsylvania, United States, 19061
        • TCV Clinical Studies
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Stern Cardiovascular Foundation
      • Jackson, Tennessee, United States, 38301
        • Apex Cardiology Research Associates of Jackson
    • Texas
      • Allen, Texas, United States, 75002-3688
        • Plano Primary Care Clinic
      • Amarillo, Texas, United States, 79106
        • Pharma Tex Research
      • Bedford, Texas, United States, 76021
        • North Hills Medical Research Inc
      • Dallas, Texas, United States, 75235
        • SW Family Medicine Associates
      • El Paso, Texas, United States, 79905
        • David Turbay MD PLLC
      • Houston, Texas, United States, 77025
        • Angiocardiac Care of Texas PA
      • Houston, Texas, United States, 77008
        • Ctr for Clin Rsch and Innovatn
      • Houston, Texas, United States, 77084
        • Dallas Heart and Vascular Consultants PA
      • Lewisville, Texas, United States, 75057
        • Epic Clinical Research
      • Lufkin, Texas, United States, 75904
        • The Heart Institute of East Texas
      • Pflugerville, Texas, United States, 78660-3015
        • Discovery Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Ctr
      • Sugar Land, Texas, United States, 77479
        • Sugar Lakes Family Practice
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Javara Research
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
      • Hopewell, Virginia, United States, 23860
        • Heart Care Associates P C
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
      • Richmond, Virginia, United States, 23298-0111
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo.
Drug: Placebo
matching placebo
Experimental: TQJ230
TQJ230 80mg QM s.c.
Drug: TQJ230
TQJ230 80mg QM s.c.
Other Names:
  • pelacarsen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in log-transformed Lp(a) concentration from baseline at week 52
Time Frame: Baseline, week 52
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
Baseline, week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence proportion of study discontinuations due to TEAEs
Time Frame: Up to 52 weeks
Incidence proportion of study discontinuations due to TEAEs will be provided
Up to 52 weeks
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
Time Frame: Up to 52 weeks
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTQJ230A12303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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