To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
300 mg SC Q4W
Sterling Research Group
Cincinnati, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Time frame: 52 weeks
Percent Change in LDL-C at 52 Weeks
percent change in serum LDL-C from baseline at 52 weeks
Time frame: 52 weeks
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