A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia

NCT07278830 | Completed Phase 2

• 1 other identifier: SAL003A201
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, 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 combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia.

Conditions

Hypercholesterolemia and Mixed Dyslipidemia

Keywords

LDL-C (Low-Density Lipoprotein Cholesterol); PCSK9 Inhibitor; SAL003

Outcome Measures

Primary Outcomes (1)

• Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)

  Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24.

  at Week 24

Study Arms (4)

Test Group Q4W

EXPERIMENTAL

Drug: SAL003 140mg+Atorvastatin

Test Group Q8W

EXPERIMENTAL

Drug: SAL003 420mg+Atorvastatin

Reference Group Q4W

PLACEBO COMPARATOR

Drug: Placebo 140mg+Atorvastatin

Reference Group Q8W

PLACEBO COMPARATOR

Drug: Placebo 420mg+Atorvastatin

Interventions

SAL003 140mg+Atorvastatin DRUG

Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.

Test Group Q4W

SAL003 420mg+Atorvastatin DRUG

Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of SAL003 was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.

Test Group Q8W

Placebo 140mg+Atorvastatin DRUG

Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of Placebo was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.

Reference Group Q4W

Placebo 420mg+Atorvastatin DRUG

Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of Placebo was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.

Reference Group Q8W

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.
• Diagnosis of hypercholesterolemia and/or mixed dyslipidemia per the 2016 Chinese guidelines.
• On a stable statin regimen as defined by the two pathways:
• Pathway 1: On other statins or irregular atorvastatin, willing to switch to/stabilize on atorvastatin.
• Pathway 2: On stable, regular atorvastatin (Lipitor) for ≥4 weeks.
• Fasting LDL-C must be above target:
• With ASCVD history: ≥1.8 mmol/L (70 mg/dL)
• Without ASCVD history: ≥2.6 mmol/L (100 mg/dL)
• Fasting triglycerides (TG) ≤ 5.6 mmol/L (500 mg/dL) at screening.
• Provide signed informed consent.

You may not qualify if:

• Suffering from homozygous familial hypercholesterolemia (HoFH); Other diseases that may cause secondary increase of LDL-C: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria;
• Route 1: The medication compliance of atorvastatin during the induction period is less than 80% or more than 120%; Route 2: The medication compliance of atorvastatin within 28 days before screening is less than 80% or more than 120%;
• Within 3 months before screening, there is heart failure (NYHA cardiac function classification of grade III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases \[such as cardiogenic shock, grade II-III atrioventricular block, bradycardia (heart rate \< 50 beats/minute), other serious arrhythmias, etc.\];
• Within 3 months before screening, there is a serious cerebrovascular disease (hypertensive encephalopathy, cerebral vascular injury, stroke, transient ischemic attack, etc.), or there is a serious aortic or peripheral vascular lesion, or there are indications for surgical intervention;
• Within 3 months before screening, there is a major surgical history or plans to undergo major surgery during the study period;
• Patients with poorly controlled hypertension (SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg);
• Diabetic patients with the following conditions known: 1) Type 1 diabetic patients; 2) Type 2 diabetic patients with poor blood sugar control (HbA1c \> 8.0%);
• Patients with active viral hepatitis (including hepatitis B and hepatitis C), other severe liver diseases, or liver dysfunction (ALT or AST \> 2.5 times the upper limit of normal, TBIL \> 2 times the upper limit of normal);
• Glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 during the screening period;
• Patients with abnormal thyroid function (thyroid stimulating hormone TSH exceeds the normal range of the center);
• CK \> 3 times the upper limit of normal during the screening period;
• Positive for AIDS or syphilis tests;
• Active malignant tumors, or patients with a history of malignant tumors within 5 years before screening (excluding skin basal cell carcinoma or cervical carcinoma in situ);
• Patients known to be allergic to the test drug or any component of the test drug, or who have had a severe allergic reaction to other antibody-based drugs;
• Patients with a history of organ transplantation;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead
• Salubris (Chengdu) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University，Guangzhou，Guangdong，510120

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 1, 2025
• First Posted: December 12, 2025
• Study Start: June 2, 2023
• Primary Completion: May 24, 2024
• Study Completion: June 7, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)