A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate … (NCT07253584) | Clinical Trial Compass
CompletedPhase 3
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
China720 participantsStarted 2023-12-19
Plain-language summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin Therapy in Patients with Hypercholesterolemia and Mixed Dyslipidemia.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* Homozygous Familial Hypercholesterolemia (HoFH).
* Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
* Significant cardiovascular event (e.g., MI, unstable angina, stroke, PCI, CABG) within 3 months prior to screening.
* 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.
* 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.