A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia

NCT07295418 | Completed Phase 3

• 1 other identifier: SAL003A301
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3 study to evaluate the efficacy and safety of SAL003, a fully human monoclonal antibody against PCSK9, as monotherapy in Chinese participants with hypercholesterolemia and mixed dyslipidemia. Participants who are not on lipid-lowering therapy or have washed out from previous therapy will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 12 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 40 weeks. The primary objective is to demonstrate the superiority of SAL003 over placebo in reducing Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12.

Conditions

Hyperlipidemias

Keywords

Low-density lipoprotein cholesterol; PCSK9; 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 12.

  at Week 12

Study Arms (2)

Test Group

EXPERIMENTAL

Drug: SAL003 140 mg

Drug: SAL003 140 mg

Reference Group

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

SAL003 140 mg DRUG

Double-blind treatment period: Administer SAL003 140mg subcutaneously once every 4 weeks for a total of 3 times. Collect efficacy and safety results after 12 weeks. Extended administration period: Administer SAL003 140mg subcutaneously once every 4 weeks and follow up until 52 weeks to collect efficacy and safety results.

Test Group

Placebo DRUG

Double-blind treatment period: Administer Placebo subcutaneously once every 4 weeks for a total of 3 times. Collect efficacy and safety results after 12 weeks. Extended administration period: Administer SAL003 140mg subcutaneously once every 4 weeks and follow up until 52 weeks to collect efficacy and safety results.

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:

• Male or female, aged 18 to 75 years (inclusive).
• Fasting LDL-C ≥2.6 mmol/L and \<4.9 mmol/L at screening/randomization.
• Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes).
• Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization.
• Provides written informed consent.

You may not qualify if:

• Diagnosis of familial hypercholesterolemia (HoFH or HeFH).
• History of atherosclerotic cardiovascular disease (ASCVD).
• Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
• Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \>8.0%).
• Significant hepatic or renal impairment.
• Active liver disease or positive for HIV or Syphilis.
• History of malignancy within 5 years prior to screening.
• Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening.
• Prior treatment with any PCSK9 inhibitor.
• Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies.
• Any other condition deemed by the investigator to be unsuitable for participation.

Sponsors & Collaborators

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

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

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

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: December 7, 2025
• First Posted: December 19, 2025
• Study Start: October 23, 2023
• Primary Completion: April 22, 2025
• Study Completion: May 8, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)