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

NCT07253584 | Completed Phase 3

• 1 other identifier: SAL003A302
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia

Keywords

Low-density lipoprotein cholesterol; PCSK9; SAL003

Outcome Measures

Primary Outcomes (1)

• Percent change of LDL-C

  Percent change from baseline in LDL-C at Week 24.

  at Week 24

Study Arms (2)

Test Group

EXPERIMENTAL

SAL003 140 mg

Drug: SAL003 140 mg

Reference Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SAL003 140 mg DRUG

SAL003 140 mg

Test Group

Placebo DRUG

Placebo

Reference Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zuyi Yuan, M.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 19, 2023
• Primary Completion: June 23, 2025
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)