Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
NCT04023552 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8323
Last updated 2026-05-06
Summary
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Conditions
- Cardiovascular Disease and Lipoprotein(a)
Interventions
- DRUG
-
TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
- DRUG
-
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-12
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- France
- Germany
- Greece
- Guatemala
- Hong Kong
- Hungary
- Iceland
- India
- Israel
- Italy
- Japan
- Mexico
- Netherlands
- Norway
- Peru
- Poland
- Portugal
- Puerto Rico
- Romania
- Russia
- Slovakia
- Slovenia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
NCT02586155 ·Status: COMPLETED ·Phase: PHASE3
-
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
NCT01975389 ·Status: TERMINATED ·Phase: PHASE3
-
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
NCT01975376 ·Status: TERMINATED ·Phase: PHASE3
-
Managed Access Programs for TQJ230, Pelacarsen
NCT07000695 ·Status: AVAILABLE
-
A Study of DII235 in Adults With Elevated Lipoprotein(a)
NCT07235046 ·Status: RECRUITING ·Phase: PHASE2
-
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
NCT04270760 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
NCT03872401 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of LCQ908 on Cardiovascular Risk
NCT01474434 ·Status: TERMINATED ·Phase: PHASE2
-
SB-480848 In Subjects With Coronary Heart Disease
NCT00269048 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
NCT02991118 ·Status: COMPLETED ·Phase: PHASE3
-
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
NCT01595854 ·Status: COMPLETED ·Phase: PHASE1
-
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
NCT01764633 ·Status: COMPLETED ·Phase: PHASE3
-
Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a
NCT03320265 ·Status: TERMINATED ·Phase: PHASE2
-
PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease
NCT00525954 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
NCT02729025 ·Status: COMPLETED ·Phase: PHASE3
-
Early Aortic Valve Lipoprotein(a) Lowering Trial
NCT02109614 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
NCT03071692 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
NCT03254446 ·Status: UNKNOWN ·Phase: PHASE3
-
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
NCT00455546 ·Status: COMPLETED ·Phase: PHASE2
-
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
NCT07157774 ·Status: RECRUITING ·Phase: PHASE3
-
Study of LC23-1306 in Healthy Male Subjects
NCT01526577 ·Status: COMPLETED ·Phase: PHASE1
-
A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
NCT01715818 ·Status: COMPLETED ·Phase: PHASE3
-
Silencing Inflammatory Activity by Injecting Nanocort in Patients at Risk for Atherosclerotic Disease
NCT01601106 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina
NCT01763996 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
NCT02993406 ·Status: COMPLETED ·Phase: PHASE3