A Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Cardiovascular Disease

Study Overview
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Brief Summary
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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)

Official Title
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A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: TQJ230
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lp(a) ≥ 70 mg/dL at the screening visit Optimal LDL-cholesterol lowering treatment Optimal treatment of other CV risk factors Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or Clinically significant symptomatic peripheral artery disease 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 μL Active liver disease or hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: TQJ230<br>* TQJ230 80 mg SC Q4W in pre-filled syringe<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Corresponding Placebo SC Q4W in pre-filled syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk reduction of expanded MACE by TQJ230 | To demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL. | 51 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE reduction by TQJ230 | Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke. | 51 months | 
| coronary heart disease (CHD) outcomes by TQJ230 | Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring hospitalization. Evaluate the rate of all cause death. | 51 months |