drugset / Trial / NCT04790513
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.
Timeline
- Start
- 2021-04-22
- Primary completion
- 2022-09-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alirocumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Comparator | Evolocumab | Monoclonal antibody | 420 mg | Subcutaneous |
| Subject | lerodalcibep | Protein / enzyme biologic | 300 mg | Subcutaneous |