drugset / Trial / NCT04797104

Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction

NCT04797104

Phase 3 Completed 478 enrolled LIB Therapeutics LLC Medpace, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with Heterozygous FH on stable diet and oral LDL-C lowering drug therapy.

Timeline

Start
2021-04-22
Primary completion
2023-07-30
Completion
2023-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject lerodalcibep Protein / enzyme biologic 300 mg Subcutaneous