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

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

Timeline

Start

2019-12-07

Primary completion

2022-09-12

Completion

2023-01-30

Publications

• Raal FJ, Mehta V, Kayikcioglu M, Blom D, Gupta P, Elis A, Turner T, Daniels C, Vest J, Mitchell T, Caldwell K, Bahassi EM, Kallend D, Stein EA. Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial. Lancet Diabetes Endocrinol. 2025 Mar;13(3):178-187. doi: 10.1016/S2213-8587(24)00313-9. Epub 2025 Jan 24.

Drugs

Indications