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

Phase 3 Unknown 900 enrolled LIB Therapeutics LLC Medpace, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2021-04-22
Primary completion: 2023-11-15
Completion: 2024-02-28

Outcome

Met primary endpoint

paper The mean (SE) placebo-adjusted reduction in LDL-C with lerodalcibep by modified intention-to-treat (mITT) analysis was 56.2% (2.2%) at week 52 PMID 38958989 ↗

paper 62.7% (1.9%) for the mean of weeks 50 and 52; 49.7% (2.4%) and 55.3% (2.2%) by ITT with imputation using a washout model, and 60.3% (2.3%) PMID 38958989 ↗

paper P < .001 for all PMID 38958989 ↗

Publications

Klug EQ, Llerena S, Burgess LJ, Fourie N, Scott R, Vest J, Caldwell K, Kallend D, Stein EA; LIBERATE-HR Investigators. Efficacy and Safety of Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease: A Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):800-807. doi: 10.1001/jamacardio.2024.1659.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lerodalcibep	Protein / enzyme biologic	300 mg	Subcutaneous