Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

Summary

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

Timeline

Start

2020-12-03

Primary completion

2025-07-30

Completion

2025-12-31

Publications

• Raal FJ, Fourie N, Scott R, Blom DJ, Basson MMV, Kayikcioglu M, Roth M, Vest J, Kallend D, Stein EA. Response to PCSK9 Inhibition Based on LDL Receptor Function in Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):593-598. doi: 10.1001/jamacardio.2026.0879.

Drugs

Indications