This study is designed to evaluate the efficacy and safety of HRS-5346 Tablets in participants with high cardiovascular event risk and elevated Lp(a), and to investigate the appropriate dosage of HRS-5346 Tablets
Understand the specific procedures of the trial, voluntarily participate in this trial, and provide written informed consent;
Aged ≥ 18 years on the day of signing the informed consent form;
Body mass index (BMI) ranging from 18.5 to 40 kg/m²;
High risk of cardiovascular events at screening;
Any of the following occurring within 3 months prior to screening, or between screening and randomization: major cardiac or non-cardiac surgery, coronary, carotid or peripheral arterial revascularization, stroke or transient ischaemic attack, myocardial infarction or unstable angina, acute limb ischaemia; as well as arrhythmias requiring treatment but uncontrolled; or other events deemed clinically unstable by the Investigator;
Participants with planned or anticipated cardiac, cerebrovascular, or peripheral arterial surgery, coronary revascularization, or other major surgery during the trial period after randomization;
History of haemorrhagic stroke or other major bleeding, or occurrence of haemorrhagic stroke or other major bleeding events between screening visit and randomization visit;
Participants with an indication for anticoagulation but not receiving anticoagulant therapy at screening;
Parallel
HRS-5346
DrugHRS-5346; Dose1
HRS-5346
DrugHRS-5346; Dose2
Percentage Change in Lp(a) Levels from Baseline to Week 12
Percentage change in Lp(a) levels from baseline to Week 4;
Absolute change in Lp(a) levels from baseline to Week 4 and Week 12;
Proportion of participants with greater than 70% reduction in Lp(a) levels from baseline at Week 4 and Week 12;
Proportion of participants achieving Lp(a) < 125 nmol/L (i.e., 50 mg/dL) at Week 4 and Week 12;
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This trial is not recruiting at the moment. You can still explore other options:
