NCT05004675

Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

Detailed description

Randomized, Open Label (lipids blinded), Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) at Day 270 of subcutaneous (SC) monthly (QM \[≤31 days\]) lerodalcibep (LIB003) 300 mg administered to SC inclisiran (Leqvio®) 284 mg at Days 1 and 90 in patients with very-high risk or high-risk CVD or at high risk for CVD with LDL-C ≥85 mg/dL on a stable diet and oral LDL-C-lowering drug therapy

Conditions

• Hypercholesterolemia
• Atherosclerotic Ischemic Disease

Interventions

Type	Name	Description
BIOLOGICAL	lerodalcibep	300 mg
DRUG	Inclisiran	284 mg

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-05-30
• Completion: 2024-10-15
• First posted: 2021-08-13
• Last updated: 2024-10-23

Locations

7 sites across 5 countries: France, Germany, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study