Clinical trial NCT06267560: Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Keywords: Elevated Lp(a)
Cardiovascular disease
Pelacarsen (TQJ230)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in log-transformed Lp(a) concentration from baseline at week 52
timeFrame: Baseline, week 52
Secondary outcomes:
measure: Incidence proportion of study discontinuations due to TEAEs
timeFrame: Up to 52 weeks
measure: Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synexus Clinical Research Advantage
state: Alabama
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research LLC
state: Alabama
city: Glendale
country: United States
facility: Synexus
state: Arizona
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic PA
state: Arkansas
city: Beverly Hills
country: United States
facility: National Heart Institute
state: California
city: Covina
country: United States
facility: Valley Clinical Trials Inc
state: California
city: Garden Grove
country: United States
facility: NICRs Research Center
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Los Angeles
country: United States
facility: Angel City Research Inc
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Trials
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Ventura Heart Institute
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials LLC
state: Florida
city: Cape Coral
country: United States
facility: C and A Clinical Trials
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research
state: Florida
city: Hialeah
country: United States
facility: National Research Institute
state: Florida
city: Hialeah
country: United States
facility: Sister Life Research Inc
state: Florida
city: Hollywood
country: United States
facility: Zenith Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinical LLC
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services LLC
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida
state: Florida
city: Miramar
country: United States
facility: Eminat LLC
state: Florida
city: Palm Springs
country: United States
facility: CTMD Research
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Plant City
country: United States
facility: Fam Medical Specialists Of Fl Plc
state: Florida
city: Tamarac
country: United States
facility: TBC Research LLC
state: Florida
city: Tampa
country: United States
facility: New Tampa Health
state: Florida
city: Tampa
country: United States
facility: James A Haley Veterans Hospital
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School Of Medicine
state: Georgia
city: Tucker
country: United States
facility: Atlanta Heart Specialists LLC
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research US Inc
state: Illinois
city: Chicago
country: United States
facility: Chicago Clinical Research Inst
state: Illinois
city: Grandwood Park
country: United States
facility: Flourish Research
state: Illinois
city: Grandwood Park
country: United States
facility: Flourish Research
state: Illinois
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: Covington
country: United States
facility: Cardiovascular Associates Research
state: Louisiana
city: Metairie
country: United States
facility: Omega Clinical Research
state: Louisiana
city: Opelousas
country: United States
facility: CV Ins of the South
state: Louisiana
city: Zachary
country: United States
facility: Southern Clin Research Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Ct for Throm Res and Drug Dev
state: Maryland
city: Baltimore
country: United States
facility: Ascension Saint Agnes Heart Care
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Univ School of Med
state: Maryland
city: Beltsville
country: United States
facility: Metropolitan Cardiovascular Consultants Llc
state: Maryland
city: Columbia
country: United States
facility: Johns Hopkins University
state: Maryland
city: Fort Washington
country: United States
facility: Anderson Medical Research
state: Maryland
city: Lanham
country: United States
facility: Capitol Cardiology Associates
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Flint Clinical Research
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Jackson
country: United States
facility: Elite Clinical Research LLC
state: Mississippi
city: Southaven
country: United States
facility: Stern Cardiovascular Foundation Inc
state: Mississippi
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: University At Buffalo
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research PLLC
state: New York
city: Asheboro
country: United States
facility: Wake Forest Health Network LLC
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clin Research Springdale
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Lima
country: United States
facility: NexGen Research
state: Ohio
city: Easton
country: United States
facility: Care Access Research
state: Pennsylvania
city: Easton
country: United States
facility: Care Access Research
state: Pennsylvania
city: Linwood
country: United States
facility: TCV Clinical Studies
state: Pennsylvania
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Jackson
country: United States
facility: Apex Cardiology Research Associates of Jackson
state: Tennessee
city: Allen
country: United States
facility: Plano Primary Care Clinic
state: Texas
city: Amarillo
country: United States
facility: Pharma Tex Research
state: Texas
city: Bedford
country: United States
facility: North Hills Medical Research Inc
state: Texas
city: Dallas
country: United States
facility: SW Family Medicine Associates
state: Texas
city: El Paso
country: United States
facility: David Turbay MD PLLC
state: Texas
city: Houston
country: United States
facility: Angiocardiac Care of Texas PA
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Marcos
country: United States
facility: Javara Research
state: Texas
city: Spring
country: United States
facility: Ctr For Clin Rsrch And Innovation
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Alexandria
country: United States
facility: Javara Research
state: Virginia
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Hopewell
country: United States
facility: Heart Care Associates P C
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research LLC
city: Humacao
country: Puerto Rico
facility: Dr Yolanda Figueroa Private Pr
city: Ponce
country: Puerto Rico
facility: CAIMED Center
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center Inc
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
city: San Juan
country: Puerto Rico
facility: Advanced Medical Research Center
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: