NCT04034485

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Homozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	lerodalcibep	PCSK9 inhibitor
DRUG	evolocumab	PCSK9 inhibitor

Timeline

• Start date: 2019-12-07
• Primary completion: 2022-09-12
• Completion: 2023-01-30
• First posted: 2019-07-26
• Last updated: 2023-03-29

Locations

12 sites across 6 countries: United States, India, Israel, Norway, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study