NCT04797247

Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction

Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.

Detailed description

Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration. Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 60 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to LIB003 or placebo. The total study duration will be up to 63 weeks which includes up to a Screening Period and 52 weeks of study drug treatment. Following randomization patients will be dosed and seen in the clinic Q4W (≤31 days).

Conditions

• Cardiovascular Diseases
• Hyper-LDL-cholesterolemia

Interventions

Type	Name	Description
DRUG	lerodalcibep	PCSK9 inhibitor

Timeline

• Start date: 2021-04-22
• Primary completion: 2023-11-15
• Completion: 2024-02-28
• First posted: 2021-03-15
• Last updated: 2023-12-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study