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COMPLETED
NCT04797104
PHASE3

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

Sponsor: LIB Therapeutics LLC

View on ClinicalTrials.gov

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.

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Heterozygous FH Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

478

Start Date

2021-04-22

Completion Date

2023-12-05

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

lerodalcibep

300 mg Q4W

Locations (7)

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, United States

Department of Medicine, Hadassah University Hospital

Jerusalem, Israel

Rabin Medical Center, Beilinson Hospital,

Petah Tikva, Israel

Lipid Clinic, Oslo University Hospital

Oslo, Norway

Carbohydrate and Lipid Metabolism Research Unit

Johannesburg, Gauteng, South Africa

Division of Lipidology, Department of Medicine University of Cape Town

Cape Town, Western Province, South Africa

Ege University Medical School

Izmir, Bornova, Turkey (Türkiye)