NCT04806893

Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction

Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease, or at High Risk for 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 CVD, or at 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 65 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 Risk Factor
• Cardiovascular Diseases
• Cardiovascular Stroke
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	lerodalcibep	300 mg subcutaneous injection every month (Q4W)
OTHER	Placebo	matching subcutaneous injection every month (Q4W)

Timeline

• Start date: 2021-04-22
• Primary completion: 2023-11-15
• Completion: 2024-02-28
• First posted: 2021-03-19
• Last updated: 2023-12-11

Locations

6 sites across 3 countries: United States, India, Israel

Regulatory

• FDA-regulated drug study