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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia
• Intervention / Treatment: Drug: Placebo; Drug: SAL003 140 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi’an, Shanxi, China
      • The First Affiliated Hospital of Xi 'An Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; SAL003 140 mg	Drug: SAL003 140 mg; SAL003 140 mg
Placebo Comparator: Reference Group; Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change of LDL-C	Percent change from baseline in LDL-C at Week 24.	at Week 24

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Zuyi Yuan, M.D, The First Affiliated Hospital of Xi 'An Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): June 23, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PCSK9; Low-density lipoprotein cholesterol; SAL003
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: SAL003A302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No