This is a randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of oral SAL0137 in adults with elevated Lp(a) and high cardiovascular risk. Participants will be randomized 1:1:1:1 to receive low-dose SAL0137, medium-dose SAL0137, high-dose SAL0137, or placebo for a treatment period of 12 weeks. The study assesses changes in Lp(a) levels and safety parameters.
Aged ≥ 18 years on the date of signing the informed consent form, male or female;
Body mass index (BMI) within the range of 18.5 to 40.0 kg/m² (inclusive);
Participants must be at elevated risk for cardiovascular events;
Lp(a) ≥ 150 nmol/L (or ≥ 60 mg/dL) at screening or prior to randomization;
Experienced any of the following within 3 months prior to screening or prior to randomization: myocardial infarction or unstable angina, stroke or transient ischemic attack, acute limb ischemia, hemorrhagic stroke or other major bleeding history, major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization; or other events that, in the investigator's opinion, indicate clinical instability;
Planned cardiac, cerebrovascular, or peripheral artery surgery, or coronary revascularization, or other major surgery after randomization;
Active malignancy, or history of malignancy within 5 years prior to screening (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that have been radically resected);
Previous history of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
Parallel
SAL0137 Dose 1
DrugSAL0137 Tablets
SAL0137 Dose 2
DrugSAL0137 Tablets
SAL0137 Dose 3
DrugSAL0137 Tablets
Placebo
DrugPlacebo
Percent Change from Baseline in Lipoprotein (a) Lp(a)
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