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Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:
Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy

Clinical Trial Summary

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Clinical Trial Description

Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04034485
Study type Interventional
Source LIB Therapeutics LLC
Contact
Status Completed
Phase Phase 3
Start date December 7, 2019
Completion date January 30, 2023
View Details
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