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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Successful completion 1 of one of the Phase 3 base studies LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to LIB003; or
* Provision of written and signed informed consent prior to any study-specific procedure;
* Female patients of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing;
* Patient is willing to maintain appropriate diet and stable dose of current lipid-lowering therapy including statins, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and
* Patient is considered by the Investigator to be otherwise healthy,
Exclusion Criteria:
* Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to study drug during the base Phase 3 study;
* Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator,
* Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months;
* Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
* Has any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks — 72 weeks Evaluation of Adverse Events based on MedRA based on ITT population
Trial sites (12)
Facility
City
Region
Status
NorthShore University Health System
Evanston
Illinois
Sterling Research Group
Cincinnati
Ohio
The Lindner Research Center
Cincinnati
Ohio
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati
Ohio
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
Division of Lipidology, Department of Medicine University of Cape Town
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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