NCT07295418

A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Safety and Efficacy of SAL003 Monotherapy in Participants With Hypercholesterolemia and Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial. The study consists of four periods: a Screening Period (up to 1 week), a Run-in Period (2 weeks), a Double-blind Treatment Period (12 weeks), and an Extended Treatment Period (40 weeks), with a total study duration of approximately 55 weeks per participant. Approximately 600 participants will be randomized. Eligible participants must be aged 18-75 years with a fasting LDL-C level between 2.6 mmol/L and 4.9 mmol/L, who are either statin-naïve or have washed out from lipid-lowering drugs for at least 3 months. Key exclusion criteria include familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), uncontrolled hypertension, poorly controlled diabetes, and significant hepatic or renal impairment. In the Double-blind Period, participants will be stratified by baseline LDL-C (\<3.4 mmol/L or ≥3.4 mmol/L) and randomized to receive either SAL003 140 mg or placebo via subcutaneous injection every 4 weeks for 3 doses (Days 1, 29, and 57). After completing the 12-week double-blind period, all participants will enter the Extended Treatment Period and receive open-label SAL003 140 mg Q4W for 10 additional doses (from Week 12 to Week 52). The primary efficacy endpoint is the percent change from baseline in LDL-C at Week 12. Key secondary endpoints include the change from baseline in LDL-C at Week 12, the proportion of participants achieving LDL-C target goals at Week 12 and Week 52, and the percent change from baseline in other lipid parameters (e.g., TC, TG, Non-HDL-C, ApoB) at Week 12 and Week 52. Safety, immunogenicity, and pharmacokinetics will be assessed throughout the study. The primary analysis will be performed on the Full Analysis Set (FAS) using a repeated measures mixed-effects model (MMRM) to compare the least-squares mean difference between the SAL003 and placebo groups at Week 12.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	SAL003 140 mg	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.
DRUG	Placebo	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.

Timeline

• Start date: 2023-10-23
• Primary completion: 2025-04-22
• Completion: 2025-05-08
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: China