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

NCT06267560 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: CTQJ230A12303
• Study Type: interventional
• Target: 422
• Locations: 2 countries
• Sites: 96

Brief Summary

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.

Conditions

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Keywords

Elevated Lp(a); Cardiovascular disease; Pelacarsen (TQJ230)

Outcome Measures

Primary Outcomes (1)

• Change in log-transformed Lp(a) concentration from baseline at 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 Outcomes (2)

• Incidence proportion of study discontinuations due to TEAEs

  Up to 52 weeks

• Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest

  Up to 52 weeks

Study Arms (2)

TQJ230

EXPERIMENTAL

TQJ230 80mg QM s.c.

Drug: TQJ230

Placebo

PLACEBO COMPARATOR

Matching placebo.

Drug: Placebo

Interventions

Placebo DRUG

matching placebo

Placebo

TQJ230 DRUG

TQJ230 80mg QM s.c.

Also known as: pelacarsen

TQJ230

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (96)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Cardiology and Medicine Clinic PA

Little Rock, Arkansas, 72204, United States

Location

National Heart Institute

Beverly Hills, California, 90211, United States

Location

Alliance Clinical

Canoga Park, California, 91303, United States

Location

Valley Clinical Trials Inc

Covina, California, 91723, United States

Location

NICRs Research Center

Garden Grove, California, 92844, United States

Location

University of Calif Irvine Med Cntr

Irvine, California, 92660, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Angel City Research Inc

Los Angeles, California, 90026, United States

Location

California Medical Research Associates Inc

Northridge, California, 91324, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Excel Medical Clinical Trials LLC

Boca Raton, Florida, 33434, United States

Location

C and A Clinical Trials

Cape Coral, Florida, 33990, United States

Location

Proactive Clinical Research

Fort Lauderdale, Florida, 33308, United States

Location

National Research Institute

Hialeah, Florida, 33013, United States

Location

Sister Life Research Inc

Hialeah, Florida, 33013, United States

Location

Zenith Clinical Research

Hollywood, Florida, 33021, United States

Location

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

Infinite Clinical Research

Miami, Florida, 33133, United States

Location

Flourish Research Miami LLC.

Miami, Florida, 33135, United States

Location

International Research Associates, LLC

Miami, Florida, 33156, United States

Location

Baptist Health South

Miami, Florida, 33173, United States

Location

A&A Research Group Inc

Miami, Florida, 33186, United States

Location

Inpatient Research Clinical LLC

Miami Lakes, Florida, 33014, United States

Location

FXM Clin Res Miramar LLC

Miramar, Florida, 33027, United States

Location

CTMD Research

Palm Springs, Florida, 33406, United States

Location

DBC Research USA

Pembroke Pines, Florida, 33029, United States

Location

New Tampa Health

Tampa, Florida, 33603, United States

Location

James A Haley Veterans Hospital

Tampa, Florida, 33612, United States

Location

Cardiology Partners Clinical Research Institute

Wellington, Florida, 33449, United States

Location

Morehouse School Of Medicine

Atlanta, Georgia, 30310, United States

Location

Atlanta Heart Specialists LLC

Tucker, Georgia, 30084, United States

Location

Synexus Clinical Research US Inc

Chicago, Illinois, 60602, United States

Location

Chicago Clinical Research Inst

Chicago, Illinois, 60607, United States

Location

Flourish Research

Grandwood Park, Illinois, 60031, United States

Location

Cardiovascular Associates Research

Covington, Louisiana, 70433, United States

Location

Omega Clinical Research

Metairie, Louisiana, 70006, United States

Location

CV Ins of the South

Opelousas, Louisiana, 70570, United States

Location

Monroe Research Llc

West Monroe, Louisiana, 71291, United States

Location

Southern Clin Research Clinic

Zachary, Louisiana, 70791, United States

Location

Sinai Ct for Throm Res and Drug Dev

Baltimore, Maryland, 21209, United States

Location

Ascension Saint Agnes Heart Care

Baltimore, Maryland, 21229, United States

Location

Johns Hopkins Univ School of Med

Baltimore, Maryland, 21287, United States

Location

Metropolitan Cardiovascular Consultants Llc

Beltsville, Maryland, 20705, United States

Location

Johns Hopkins University

Columbia, Maryland, 21044, United States

Location

Anderson Medical Research

Ft. Washington, Maryland, 20744, United States

Location

Capitol Cardiology Associates

Lanham, Maryland, 20706, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Aa Mrc Mhs

Flint, Michigan, 48503, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Elite Clinical Research LLC

Jackson, Mississippi, 39202, United States

Location

Stern Cardiovascular Foundation Inc

Southaven, Mississippi, 38671, United States

Location

Las Vegas Endocrinology

Henderson, Nevada, 89074, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

Clinical Research of South Nevada

Las Vegas, Nevada, 89121, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Jamaica Hospital Medical Center

Richmond Hill, New York, 11418, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Alliance Medical Ministry

Raleigh, North Carolina, 27610, United States

Location

Velocity Clin Research Springdale

Cincinnati, Ohio, 45246, United States

Location

NexGen Research

Lima, Ohio, 45801, United States

Location

Care Access Research

Easton, Pennsylvania, 18045, United States

Location

TCV Clinical Studies

Linwood, Pennsylvania, 19061, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Apex Cardiology Research Associates of Jackson

Jackson, Tennessee, 38301, United States

Location

Plano Primary Care Clinic

Allen, Texas, 75002-3688, United States

Location

Pharma Tex Research

Amarillo, Texas, 79106, United States

Location

North Hills Medical Research Inc

Bedford, Texas, 76021, United States

Location

SW Family Medicine Associates

Dallas, Texas, 75235, United States

Location

David Turbay MD PLLC

El Paso, Texas, 79905, United States

Location

Ctr for Clin Rsch and Innovatn

Houston, Texas, 77008, United States

Location

Angiocardiac Care of Texas PA

Houston, Texas, 77025, United States

Location

Dallas Heart and Vascular Consultants PA

Houston, Texas, 77084, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

The Heart Institute of East Texas

Lufkin, Texas, 75904, United States

Location

Discovery Clinical Trials

Pflugerville, Texas, 78660-3015, United States

Location

University of Texas Health Science Ctr

San Antonio, Texas, 78229-3900, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States

Location

Javara Research

Alexandria, Virginia, 22311, United States

Location

Virginia Heart

Falls Church, Virginia, 22042, United States

Location

Heart Care Associates P C

Hopewell, Virginia, 23860, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-0111, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Advanced Clinical Research LLC

Bayamón, 00959, Puerto Rico

Location

Dr Yolanda Figueroa Private Pr

Humacao, 00791, Puerto Rico

Location

CAIMED Center

Ponce, 00716, Puerto Rico

Location

Research and Cardiovascular Corp

Ponce, 00717-1322, Puerto Rico

Location

Latin Clinical Trial Center Inc

San Juan, 00909, Puerto Rico

Location

VA Caribbean Healthcare System

San Juan, 00921, Puerto Rico

Location

Advance Medical Research Center

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

pelacarsen

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: April 24, 2024
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (89); PR (7)