Clinical Trial

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

Study acronym: LIBerate-OLE
Enrolling by Invitation Phase 3
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Record status
This record was last updated October 22, 2024 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-03-11; most recent amendment 2024-10-21.
Trial Details
NCT Number NCT04798430
Lead Sponsor LIB Therapeutics LLC
Collaborators: Medpace, Inc.
Conditions Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
Enrollment 2,000 participants
Start Date 2020-12-03
Primary Completion 2025-07-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-22