This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Active experimental drug
Active experimental drug
Placebo comparator
Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Miramar, Florida, United States
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
Time frame: 12 weeks
Plasma concentrations of LGT209 following subcutaneous administration
Time frame: 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
Time frame: baseline and 12 weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
Time frame: baseline and 12 weeks
Plasma concentrations of atorvastatin in patients
Time frame: 2 weeks
Plasma concentrations of simvastatin in patients
Time frame: 2 weeks
Serum concentrations of PCSK9
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stable doses of atorvastatin or simvastatin