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

August 6, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
422

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

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, 33173
        • Baptist Health South
      • Miami, Florida, United States, 33135
        • Flourish Research Miami LLC
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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