Phase 2Completed
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) Combined With Atorvastatin in Subjects With Hypercholesterolemia and Mixed Dyslipidemia
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd. (Industry)
- Enrolment
- 214 enrolled
- Conditions
- Hypercholesterolemia and Mixed Dyslipidemia
- Interventions
- SAL003 140mg+Atorvastatin; SAL003 420mg+Atorvastatin; Placebo 140mg+Atorvastatin; Placebo 420mg+Atorvastatin
- Ages
- adults, older adults
- Registry
- NCT07278830
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)
History
Registered
Study completion
Primary completion
Started