drugset / Trial / NCT07253584

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia

NCT07253584

Phase 3 Completed 720 enrolled Shenzhen Salubris Pharmaceuticals Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin Therapy in Patients with Hypercholesterolemia and Mixed Dyslipidemia.

Timeline

Start
2023-12-19
Primary completion
2025-06-23
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SAL003 Monoclonal antibody 140 mg Subcutaneous