drugset / Trial / NCT07278830
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
Phase 2
Completed
214 enrolled
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Salubris (Chengdu) Biotechnology Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-06-02
- Primary completion
- 2024-05-24
- Completion
- 2024-06-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAL003 | Monoclonal antibody | 140 mg | — |
| Subject | SAL003 | Monoclonal antibody | 420 mg | — |
| Background | Atorvastatin | Small molecule | — | — |