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

NCT07278830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

DRUG

SAL003 140mg+Atorvastatin

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.

DRUG

SAL003 420mg+Atorvastatin

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.

DRUG

Placebo 140mg+Atorvastatin

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.

DRUG

Placebo 420mg+Atorvastatin

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.

Sponsors & Collaborators

  • Salubris (Chengdu) Biotechnology Co., Ltd.

    collaborator UNKNOWN

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2024-05-24
Completion
2024-06-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278830 on ClinicalTrials.gov