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)
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)
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).
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.
Key Inclusion criteria:
Key Exclusion Criteria:
Prior treatment with inclisiran
Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
Uncontrolled hypertension at Randomization/Baseline visit
Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
Triglycerides ≥400 mg/dL at Screening visit
History of malignancy of any organ system within the past 5 years
Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
Central laboratory reported platelet count <140,000 per mm3
Active liver disease or hepatic dysfunction at Screening visit
Significant kidney disease at Screening visit
Pregnant or nursing women at Screening visit
Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit
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