The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
This trial plans to enroll 900 Participants.
Age of 18 - 75 years (inclusive);
Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;
Very high risk: 55 mg/dL (1.4 mmol/L) ≤ LDL-C < 188 mg/dL (4.9 mmol/L);
Extremely high risk: LDL-C ≥ 70 mg/dL (1.8 mmol/L);
Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；
Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy within the past 2 years before screening;
History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
Systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg during the Screening Period or prior to Randomization;
Parallel
SYH2053/placebo injection
DrugParticipants receive SYH2053/placebo injection by subcutaneous administration.
Percentage change in LDL-C relative to baseline
The value of change in LDL-C relative to baseline
Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels
Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description:
Number of ADA and Nab
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This trial is not recruiting at the moment. You can still explore other options:
