The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
TG ≤ 5.6 mmol/L.
LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.
History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
Acute ischemic ASCVD events within 3 months prior to screening or randomization.
Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
Parallel
SHR-1918 Injection
DrugSHR-1918 injection.
SHR-1918 Injection Placebo
DrugSHR-1918 injection placebo.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.
Phase 2.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline.
Phase 3.
Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.
Phase 2.
Percentage change in triglyceride (TG) relative to baseline.
Phase 2.
Percentage change in total cholesterol (TC) relative to baseline.
Phase 2.
Percentage change in apolipoprotein B (ApoB) relative to baseline.
Phase 2.
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