A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia

Prior treatment

• Significant cardiovascular event (e.g., MI, unstable angina, stroke, PCI, CABG) within 3 months prior to screening.
• Use of other lipid-lowering therapies (e.g., fibrates, niacin) within 3 months or any PCSK9 inhibitor within 6 months prior to screening.
• Known hypersensitivity to any component of the investigational product or other antibody therapies.

Other illness

• Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).

Lab values

• Heart failure (NYHA Class III or IV) or LVEF \<40% within 3 months.
• Severe renal impairment (eGFR \<30 mL/min/1.73m²).
• Active liver disease or significant hepatic impairment (ALT/AST \>2.5x ULN or TBiL \>2x ULN).
• Uncontrolled diabetes (HbA1c \>8.0%) or type 1 diabetes.

Other

• Homozygous Familial Hypercholesterolemia (HoFH).

• Subjects aged 18 to 75 years.
• On a stable, moderate- to high-intensity statin regimen (with or without ezetimibe) for at least 4 weeks prior to screening.
• Fasting LDL-C above target levels per 2023 Chinese guidelines:
  • With ASCVD history: ≥1.4 mmol/L (Extreme Risk) or ≥1.8 mmol/L (Very High Risk). Without ASCVD history: ≥2.6 mmol/L (Moderate/High Risk) or ≥3.4 mmol/L (Low Risk).
  • Fasting triglycerides (TG) ≤ 5.6 mmol/L at screening/randomization.
• Provide signed informed consent.