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

Salubris Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia

Treatments

Drug: SAL003 140 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07253584

SAL003A302

Details and patient eligibility

About

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.

Full description

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in Chinese patients with hypercholesterolemia and mixed dyslipidemia at very high or high cardiovascular risk who have not achieved target LDL-C levels despite stable, moderate- to high-intensity statin therapy (with or without ezetimibe).

Approximately 720 participants will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 24 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 28 weeks, with a total study duration of 52 weeks.

The primary efficacy endpoint is the percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24. Key secondary endpoints include the absolute change in LDL-C, the proportion of subjects achieving LDL-C target levels, and changes in other lipid parameters.

Enrollment

720 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.