A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
• 、Age ≥18 years (inclusive);
• 、Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):① Low risk: LDL-C ≥130 mg/dL（3.4 mmol/L）and LDL-C\<188 mg/dL（4.9 mmol/L）; ②Moderate risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L) and LDL-C\<188 mg/dL（4.9 mmol/L）; 3、At screening (based on local laboratory results), Fasting serum Triglyceride (TG)\<500 mg/dL（5.6 mmol/L） 4、Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.