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Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction — LIBerate-CVD  

Cardiovascular Diseases Clinical Trial

Official title:
Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Clinical Trial Summary

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.

Clinical Trial Description

Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration. Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 60 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to LIB003 or placebo. The total study duration will be up to 63 weeks which includes up to a Screening Period and 52 weeks of study drug treatment. Following randomization patients will be dosed and seen in the clinic Q4W (≤31 days). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04797247
Study type Interventional
Source LIB Therapeutics LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 22, 2021
Completion date February 28, 2024
View Details
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