A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hyp… (NCT07421284) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
China900 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. 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):
✓. 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);
✓. Moderate to high risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L);
✓. Low risk: LDL-C ≥ 130 mg/dL (3.4 mmol/L); 4.Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Exclusion criteria
✕. 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;
✕. History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF \< 40% within 180 days before screening;
✕. eGFR \< 30 mL/min/1.73 m² during the Screening Period or prior to Randomization;
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × ULN or Total Bilirubin (TBIL), \> 1.5 × ULN at Screening Period or prior to Randomization;