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ENROLLING BY INVITATION
NCT04798430
PHASE3

Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

Sponsor: LIB Therapeutics LLC

View on ClinicalTrials.gov

Summary

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

Official title: Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2020-12-03

Completion Date

2025-12-31

Last Updated

2024-10-22

Healthy Volunteers

No

Interventions

DRUG

lerodalcibep

PCSK9 inhibitor

Locations (12)

NorthShore University Health System

Evanston, Illinois, United States

Sterling Research Group

Cincinnati, Ohio, United States

The Lindner Research Center

Cincinnati, Ohio, United States

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, United States

G.B. Pant Institute of Postgraduate Medical Education & Research

New Delhi, India

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)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Turkey (Türkiye)