New drug targets hidden heart risk in black and hispanic communities

NCT ID NCT06267560

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tested a drug called pelacarsen in 422 Black/African American and Hispanic patients with high Lp(a) levels and existing heart disease. Lp(a) is a genetic risk factor for heart attacks and strokes. The goal was to see if pelacarsen could safely lower Lp(a) levels over 12 months compared to a placebo. The trial is complete, and results will help determine if this drug could reduce heart disease in these populations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: pelacarsen (TQJ230)
What this could lead to: If successful, pelacarsen could provide a new way to lower Lp(a) levels and reduce heart disease risk in Black and Hispanic populations, who are often underrepresented in research.
What could go wrong: This trial is completed but results are not yet published. It focuses on a biomarker (Lp(a) levels) rather than directly measuring heart attacks or strokes, so benefits remain uncertain. Side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

422 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elevated LP(A) and established atherosclerotic cardiovascular disease

Contacts and locations

Locations

A&A Research Group Inc

Miami, Florida, 33186, United States
AB Clinical Trials

Las Vegas, Nevada, 89119, United States
Aa Mrc Llc

Flint, Michigan, 48504, United States
Aa Mrc Mhs

Flint, Michigan, 48503, United States
Acclaim Clinical Research

San Diego, California, 92120, United States
Advance Medical Research Center

San Juan, 00926, Puerto Rico
Advanced Clinical Research LLC

Bayamón, 00959, Puerto Rico
Alliance Clinical

Canoga Park, California, 91303, United States
Alliance Medical Ministry

Raleigh, North Carolina, 27610, United States
Anderson Medical Research

Ft. Washington, Maryland, 20744, United States
Angel City Research Inc

Los Angeles, California, 90026, United States
Angiocardiac Care of Texas PA

Houston, Texas, 77025, United States
Apex Cardiology Research Associates of Jackson

Jackson, Tennessee, 38301, United States
Ascension Saint Agnes Heart Care

Baltimore, Maryland, 21229, United States
Atlanta Heart Specialists LLC

Tucker, Georgia, 30084, United States
Baptist Health South

Miami, Florida, 33173, United States
C and A Clinical Trials

Cape Coral, Florida, 33990, United States
CAIMED Center

Ponce, 00716, Puerto Rico
CTMD Research

Palm Springs, Florida, 33406, United States
CV Ins of the South

Opelousas, Louisiana, 70570, United States
California Medical Research Associates Inc

Northridge, California, 91324, United States
Capitol Cardiology Associates

Lanham, Maryland, 20706, United States
Cardiology Partners Clinical Research Institute

Wellington, Florida, 33449, United States
Cardiology and Medicine Clinic PA

Little Rock, Arkansas, 72204, United States
Cardiovascular Associates Research

Covington, Louisiana, 70433, United States
Care Access Research

Easton, Pennsylvania, 18045, United States
Chicago Clinical Research Inst

Chicago, Illinois, 60607, United States
Clinical Research of South Nevada

Las Vegas, Nevada, 89121, United States
Clinical Trials of Texas

San Antonio, Texas, 78229, United States
Columbus Clinical Services LLC

Miami, Florida, 33125, United States
Ctr for Clin Rsch and Innovatn

Houston, Texas, 77008, United States
DBC Research USA

Pembroke Pines, Florida, 33029, United States
Dallas Heart and Vascular Consultants PA

Houston, Texas, 77084, United States
David Turbay MD PLLC

El Paso, Texas, 79905, United States
Discovery Clinical Trials

Pflugerville, Texas, 78660-3015, United States
Dominion Medical Associates

Richmond, Virginia, 23219, United States
Dr Yolanda Figueroa Private Pr

Humacao, 00791, Puerto Rico
Elite Clinical Research LLC

Jackson, Mississippi, 39202, United States
Epic Clinical Research

Lewisville, Texas, 75057, United States
Excel Medical Clinical Trials LLC

Boca Raton, Florida, 33434, United States
FXM Clin Res Miramar LLC

Miramar, Florida, 33027, United States
Finlay Medical Research

Miami, Florida, 33126, United States
Flourish Research

Winter Park, Florida, 32789, United States
Flourish Research Miami LLC

Miami, Florida, 33135, United States
Heart Care Associates P C

Hopewell, Virginia, 23860, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Infinite Clinical Research

Miami, Florida, 33133, United States
Inpatient Research Clinical LLC

Miami Lakes, Florida, 33014, United States
International Research Associates LLC

Miami, Florida, 33156, United States
Jamaica Hospital Medical Center

Richmond Hill, New York, 11418, United States
James A Haley Veterans Hospital

Tampa, Florida, 33612, United States
Javara Research

Alexandria, Virginia, 22311, United States
Johns Hopkins Univ School of Med

Baltimore, Maryland, 21287, United States
Johns Hopkins University

Columbia, Maryland, 21044, United States
Las Vegas Endocrinology

Henderson, Nevada, 89074, United States
Latin Clinical Trial Center Inc

San Juan, 00909, Puerto Rico
Long Beach Clinical Trials

Long Beach, California, 90806, United States
MD Medical Research

Oxon Hill, Maryland, 20745, United States
Metropolitan Cardiovascular Consultants Llc

Beltsville, Maryland, 20705, United States
Monroe Biomedical Research

Monroe, North Carolina, 28112, United States
Monroe Research Llc

West Monroe, Louisiana, 71291, United States
Morehouse School Of Medicine

Atlanta, Georgia, 30310, United States
NICRs Research Center

Garden Grove, California, 92844, United States
National Heart Institute

Beverly Hills, California, 90211, United States
National Research Institute

Hialeah, Florida, 33013, United States
New Tampa Health

Tampa, Florida, 33603, United States
NexGen Research

Lima, Ohio, 45801, United States
North Hills Medical Research Inc

Bedford, Texas, 76021, United States
Omega Clinical Research

Metairie, Louisiana, 70006, United States
Overlook Medical Center

Summit, New Jersey, 07901, United States
Parkway Medical Center

Birmingham, Alabama, 35215, United States
Pharma Tex Research

Amarillo, Texas, 79106, United States
Plano Primary Care Clinic

Allen, Texas, 75002-3688, United States
Proactive Clinical Research

Fort Lauderdale, Florida, 33308, United States
Research and Cardiovascular Corp

Ponce, 00717-1322, Puerto Rico
Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States
SW Family Medicine Associates

Dallas, Texas, 75235, United States
Sinai Ct for Throm Res and Drug Dev

Baltimore, Maryland, 21209, United States
Sister Life Research Inc

Hialeah, Florida, 33013, United States
Southern Clin Research Clinic

Zachary, Louisiana, 70791, United States
Stanford University Medical Center

Palo Alto, California, 94304, United States
Stern Cardiovascular Foundation Inc

Southaven, Mississippi, 38671, United States
Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States
Synexus Clinical Research US Inc

Chicago, Illinois, 60602, United States
TCV Clinical Studies

Linwood, Pennsylvania, 19061, United States
The Heart Institute of East Texas

Lufkin, Texas, 75904, United States
The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States
University of Calif Irvine Med Cntr

Irvine, California, 92660, United States
University of Texas Health Science Ctr

San Antonio, Texas, 78229-3900, United States
University of Washington

Seattle, Washington, 98195, United States
VA Caribbean Healthcare System

San Juan, 00921, Puerto Rico
Valley Clinical Trials Inc

Covina, California, 91723, United States
Velocity Clin Research Springdale

Cincinnati, Ohio, 45246, United States
Virginia Commonwealth University

Richmond, Virginia, 23298-0111, United States
Virginia Heart

Falls Church, Virginia, 22042, United States
Zenith Clinical Research

Hollywood, Florida, 33021, United States