Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
Launched by NOVARTIS PHARMACEUTICALS · Feb 12, 2024
Trial Information
Current as of April 25, 2025
Recruiting
Keywords
ClinConnect Summary
The Lp(a) Lowering Study of Pelacarsen is a research trial aimed at understanding how well a new medication called pelacarsen works to lower high levels of lipoprotein(a), or Lp(a), in Black/African American and Hispanic participants who have heart disease. This study is specifically for adults aged 18 to 80 who have already been diagnosed with atherosclerotic cardiovascular disease (ASCVD) and have high Lp(a) levels. Participants must also be receiving standard treatment for heart disease risk factors like high cholesterol, high blood pressure, or diabetes.
If you or a loved one qualify, you will be randomly assigned to receive either pelacarsen or a placebo (a treatment that looks like the real drug but has no active ingredients) for a set period of time. Throughout the study, researchers will monitor your health to assess how well the medication works and whether it is safe to use. It's important to note that certain health conditions, like uncontrolled high blood pressure or serious kidney problems, may prevent participation in this trial. Overall, this study aims to find better treatments for those at risk of heart problems due to high Lp(a) levels.
Gender
ALL
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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Atlanta, Georgia, United States
Jamaica, New York, United States
Atlanta, Georgia, United States
San Antonio, Texas, United States
Birmingham, Alabama, United States
Columbia, Maryland, United States
Oxon Hill, Maryland, United States
Miami, Florida, United States
Buffalo, New York, United States
San Juan, , Puerto Rico
Los Angeles, California, United States
Wellington, Florida, United States
Richmond, Virginia, United States
Falls Church, Virginia, United States
Summit, New Jersey, United States
Germantown, Tennessee, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Alexandria, Louisiana, United States
Flint, Michigan, United States
Long Beach, California, United States
Flint, Michigan, United States
Miami, Florida, United States
Metairie, Louisiana, United States
Pembroke Pines, Florida, United States
Sugar Land, Texas, United States
Huntsville, Alabama, United States
Houston, Texas, United States
Miami, Florida, United States
Amarillo, Texas, United States
Boca Raton, Florida, United States
Columbus, Ohio, United States
Monroe, North Carolina, United States
Covington, Louisiana, United States
Houston, Texas, United States
Beltsville, Maryland, United States
Miami, Florida, United States
Henderson, Nevada, United States
Lewisville, Texas, United States
Palm Springs, Florida, United States
San Diego, California, United States
Hialeah, Florida, United States
Jackson, Tennessee, United States
Ponce, , Puerto Rico
Miramar, Florida, United States
Tampa, Florida, United States
El Paso, Texas, United States
San Marcos, Texas, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Fort Washington, Maryland, United States
Tampa, Florida, United States
Beverly Hills, California, United States
Baltimore, Maryland, United States
Miami Lakes, Florida, United States
Plant City, Florida, United States
Zachary, Louisiana, United States
Bayamon, , Puerto Rico
Chicago, Illinois, United States
Baltimore, Maryland, United States
Lanham, Maryland, United States
Las Vegas, Nevada, United States
Bedford, Texas, United States
San Juan, , Puerto Rico
Birmingham, Alabama, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Tucker, Georgia, United States
Alexandria, Louisiana, United States
Opelousas, Louisiana, United States
Dallas, Texas, United States
Chicago, Illinois, United States
Easton, Pennsylvania, United States
Cincinnati, Ohio, United States
New Windsor, New York, United States
Baltimore, Maryland, United States
Hopewell, Virginia, United States
Little Rock, Arkansas, United States
Covina, California, United States
Cape Coral, Florida, United States
San Antonio, Texas, United States
Spring, Texas, United States
Lima, Ohio, United States
Bedford, Texas, United States
Pflugerville, Texas, United States
San Juan, , Puerto Rico
Glendale, Arizona, United States
Little Rock, Arkansas, United States
Garden Grove, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Thousand Oaks, California, United States
Tamarac, Florida, United States
Grandwood Park, Illinois, United States
Zachary, Louisiana, United States
Jackson, Mississippi, United States
Southaven, Mississippi, United States
Asheboro, North Carolina, United States
Linwood, Pennsylvania, United States
Allen, Texas, United States
Spring, Texas, United States
Alexandria, Virginia, United States
Richmond, Virginia, United States
Humacao, , Puerto Rico
Ponce, , Puerto Rico
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported