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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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04806893
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

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