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Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2025-04-30
Completion Date
2028-02-29
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
Pelacarsen
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Placebo
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
Inclisiran
All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.
Locations (80)
Parkway Medical Center
Birmingham, Alabama, United States
Clinical Research Inst of Arizona
Sun City West, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Interv Cardiology Med Grp
West Hills, California, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Jacksonville Center for Clinical
Jacksonville, Florida, United States
K2 Medical Research LLC
Maitland, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Miami Cancer Institute at Bapt
Miami, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
FXM Clin Res Miramar LLC
Miramar, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
SEC Clinical Research
Pensacola, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
FC Site Partners Miami
Winter Park, Florida, United States
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois, United States
American Health Network Research Dept
Muncie, Indiana, United States
American Health Network Research Dept
Muncie, Indiana, United States
Cardiovascular Associates Research
Covington, Louisiana, United States
Omega Clinical Research
Metairie, Louisiana, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Overlook Medical Center
Summit, New Jersey, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
The Corvallis Clinic P C
Corvallis, Oregon, United States
Novartis Investigative Site
Tullahoma, Tennessee, United States
PharmaTex Research LLC
Amarillo, Texas, United States
Kelsey Seybold Research Foundation
Houston, Texas, United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Heart
Falls Church, Virginia, United States
Novartis Investigative Site
Yinchuan, Ningxia, China
Novartis Investigative Site
Jining, Shandong, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Poitiers, France
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany
Novartis Investigative Site
Potsdam, Brandenburg, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bielefeld, Germany
Novartis Investigative Site
Gelnhausen, Germany
Novartis Investigative Site
Mannheim, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Singen, Germany
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Caserta, CE, Italy
Novartis Investigative Site
Grosseto, GR, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
The Hague, South Holland, Netherlands
Novartis Investigative Site
Enschede, Netherlands
Latin Clinical Trial Center Inc
San Juan, Puerto Rico
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Castilleja de la Cuesta, Sevilla, Spain
Novartis Investigative Site
A Coruña, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Huelva, Spain
Novartis Investigative Site
Las Palmas GC, Spain
Novartis Investigative Site
Salamanca, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Tainan, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Chichester, West Sussex, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Novartis Investigative Site
Tyne and Wear, United Kingdom