A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.

Inclusion criteria

• Male or female participants ≥18 years of age;
• Elevated Lp(a);
• Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;
• Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
• Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.

Exclusion criteria

• Diseases that significantly affect Lp(a) during screening period,
• Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
• Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;
• NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
• Type 1 diabetes or hereditary hemorrhagic disorder at screening;
• History of malignant tumor or suspected malignancy within 5 years prior to screening;
• Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
• Allergy to oligonucleotide drugs;
• Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
• Female participants who are pregnant or breastfeeding at screening, or female / male participants who plan to conceive during the study and within 1 year after the last dose.