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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
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
Conditions
Interventions
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)