Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction — LIBerate-HR  

Cardiovascular Diseases Clinical Trial

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

Status Active, not recruiting

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 CVD, or at 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 65 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). ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Cardiovascular Stroke
• Hypercholesterolemia
• Myocardial Infarction

• NCT number: NCT04806893
• Study type: Interventional
• Source: LIB Therapeutics LLC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 22, 2021
• Completion date: February 28, 2024