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.
The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012). Patients will continue to maintain their existing oral lipid-lowering therapy (LLT). Following completion of a base study and providing informed consent, patients will receive doses of LIB003 300 mg Q4W (\<31 days) on Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68. Patients will be seen in the clinic Q4W (\<31 days) for at least the initial 12 weeks and then every 12 weeks (Weeks 24, 36, 48, 60, and 72) with the interim Q4W (\<31 days) doses administered at home. Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial. Their lipids will remain blinded (to patient, study staff and sponsor) until week 4 to avoid any unblinding of the prior trial. Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
PCSK9 inhibitor
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
...and 2 more locations
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks
Evaluation of Adverse Events based on MedRA based on ITT population
Time frame: 72 weeks
Immunogenicity
Incidence of anti-drug antibodies
Time frame: 72 weeks
LDL Cholesterol reduction
Percent decrease in LDL-C from baseline of original study
Time frame: 72 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.