Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
- Conditions
- Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06267560
- Lead Sponsor
- Novartis Pharmaceuticals
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
-
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):
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQJ230 TQJ230 TQJ230 80mg QM s.c. Placebo Placebo Matching placebo.
- Primary Outcome Measures
Name Time Method Change in log-transformed Lp(a) concentration from baseline at week 52 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.
- Secondary Outcome Measures
Name Time Method Incidence proportion of study discontinuations due to TEAEs Up to 52 weeks Incidence proportion of study discontinuations due to TEAEs will be provided
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest Up to 52 weeks Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided
Trial Locations
- Locations (100)
Synexus Clinical Research Advantage
🇺🇸Birmingham, Alabama, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Optimal Research LLC
🇺🇸Huntsville, Alabama, United States
Synexus
🇺🇸Glendale, Arizona, United States
Cardiology and Medicine Clinic PA
🇺🇸Little Rock, Arkansas, United States
National Heart Institute
🇺🇸Beverly Hills, California, United States
Valley Clinical Trials Inc
🇺🇸Covina, California, United States
NICRs Research Center
🇺🇸Garden Grove, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
Angel City Research Inc
🇺🇸Los Angeles, California, United States
Velocity Clinical Trials
🇺🇸Los Angeles, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
Ventura Heart Institute
🇺🇸Thousand Oaks, California, United States
Excel Medical Clinical Trials LLC
🇺🇸Boca Raton, Florida, United States
C and A Clinical Trials
🇺🇸Cape Coral, Florida, United States
Proactive Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
National Research Institute
🇺🇸Hialeah, Florida, United States
Sister Life Research Inc
🇺🇸Hialeah, Florida, United States
Zenith Clinical Research
🇺🇸Hollywood, Florida, United States
Inpatient Research Clinical LLC
🇺🇸Miami Lakes, Florida, United States
Columbus Clinical Services LLC
🇺🇸Miami, Florida, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Baptist Health Medical Group
🇺🇸Miami, Florida, United States
Clinical Trials of Florida
🇺🇸Miami, Florida, United States
Eminat LLC
🇺🇸Miramar, Florida, United States
CTMD Research
🇺🇸Palm Springs, Florida, United States
DBC Research USA
🇺🇸Pembroke Pines, Florida, United States
Fam Medical Specialists Of Fl Plc
🇺🇸Plant City, Florida, United States
TBC Research LLC
🇺🇸Tamarac, Florida, United States
New Tampa Health
🇺🇸Tampa, Florida, United States
James A Haley Veterans Hospital
🇺🇸Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
🇺🇸Wellington, Florida, United States
Grady Health System
🇺🇸Atlanta, Georgia, United States
Morehouse School Of Medicine
🇺🇸Atlanta, Georgia, United States
Atlanta Heart Specialists LLC
🇺🇸Tucker, Georgia, United States
Synexus Clinical Research US Inc
🇺🇸Chicago, Illinois, United States
Chicago Clinical Research Inst
🇺🇸Chicago, Illinois, United States
Flourish Research
🇺🇸Grandwood Park, Illinois, United States
Cambridge Medical Trials
🇺🇸Alexandria, Louisiana, United States
Cardiovascular Associates Research
🇺🇸Covington, Louisiana, United States
Omega Clinical Research
🇺🇸Metairie, Louisiana, United States
CV Ins of the South
🇺🇸Opelousas, Louisiana, United States
Southern Clin Research Clinic
🇺🇸Zachary, Louisiana, United States
Sinai Ct for Throm Res and Drug Dev
🇺🇸Baltimore, Maryland, United States
Ascension Saint Agnes Heart Care
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Univ School of Med
🇺🇸Baltimore, Maryland, United States
Metropolitan Cardiovascular Consultants Llc
🇺🇸Beltsville, Maryland, United States
Johns Hopkins University
🇺🇸Columbia, Maryland, United States
Anderson Medical Research
🇺🇸Fort Washington, Maryland, United States
Capitol Cardiology Associates
🇺🇸Lanham, Maryland, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Flint Clinical Research
🇺🇸Flint, Michigan, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, United States
Elite Clinical Research LLC
🇺🇸Jackson, Mississippi, United States
Stern Cardiovascular Foundation Inc
🇺🇸Southaven, Mississippi, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
University At Buffalo
🇺🇸Buffalo, New York, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Mid Hudson Medical Research PLLC
🇺🇸New Windsor, New York, United States
Wake Forest Health Network LLC
🇺🇸Asheboro, North Carolina, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Velocity Clin Research Springdale
🇺🇸Cincinnati, Ohio, United States
Hometown Urgent Care and Research
🇺🇸Columbus, Ohio, United States
NexGen Research
🇺🇸Lima, Ohio, United States
Care Access Research
🇺🇸Easton, Pennsylvania, United States
TCV Clinical Studies
🇺🇸Linwood, Pennsylvania, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Apex Cardiology Research Associates of Jackson
🇺🇸Jackson, Tennessee, United States
Plano Primary Care Clinic
🇺🇸Allen, Texas, United States
Pharma Tex Research
🇺🇸Amarillo, Texas, United States
North Hills Medical Research Inc
🇺🇸Bedford, Texas, United States
SW Family Medicine Associates
🇺🇸Dallas, Texas, United States
David Turbay MD PLLC
🇺🇸El Paso, Texas, United States
Angiocardiac Care of Texas PA
🇺🇸Houston, Texas, United States
Biopharma Informatic LLC
🇺🇸Houston, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
Discovery Clinical Trials
🇺🇸Pflugerville, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Javara Research
🇺🇸Alexandria, Virginia, United States
Ctr For Clin Rsrch And Innovation
🇺🇸Spring, Texas, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Virginia Heart
🇺🇸Falls Church, Virginia, United States
Heart Care Associates P C
🇺🇸Hopewell, Virginia, United States
Dominion Medical Associates
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Advanced Clinical Research LLC
🇵🇷Bayamon, Puerto Rico
Dr Yolanda Figueroa Private Pr
🇵🇷Humacao, Puerto Rico
CAIMED Center
🇵🇷Ponce, Puerto Rico
Research and Cardiovascular Corp
🇵🇷Ponce, Puerto Rico
Latin Clinical Trial Center Inc
🇵🇷San Juan, Puerto Rico
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Advanced Medical Research Center
🇵🇷San Juan, Puerto Rico