NCT04790513

Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients

Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003, Evolocumab and Alirocumab in CVD Patients, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction (LIBerate-H2H)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.

Detailed description

This is a randomized, open-label Phase 3 study of 12 weeks duration comparing Q4W SC doses of LIB003 300 mg, evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg. Approximately 220 males and females aged ≥18 years who fulfill all of the inclusion and exclusion criteria will be enrolled at up to 25 sites in the United States. Patients will be stratified by baseline LDL-C and randomized in a 2:2:1 ratio to LIB003 (88 patients), Repatha (88 patients) or Praluent (44 patients) administered SC Q4W (≤31 days). The study will consist of a Screening Period and a Treatment Period. The total study duration will be up to 21 weeks which includes up to 9-week Screening Period (depending on period required for washout of PCSK9 mAb and/or intensification of statin treatment) and 12 weeks of study drug treatment.

Conditions

• Hypercholesterolemia
• Cardiovascular Diseases

Interventions

Type	Name	Description
BIOLOGICAL	lerodalcibep	anti-PCSK9 small binding protein
BIOLOGICAL	evolocumab	monoclonal antibody to PCSK9
BIOLOGICAL	alirocumab	monoclonal antibody to PCSK9

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2021-03-10
• Last updated: 2023-03-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study