This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Fenofibrate once daily 12 weeks
Fish Oil once daily for 12 weeks
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
Time frame: Baseline, 6 weeks
Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks
Time frame: Baseline, 12 weeks
Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks
Time frame: Baseline, 6 weeks
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks
Time frame: Baseline, 12 weeks
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death
Time frame: 12 weeks
changefrom baseline in lipids and lipoprotein profiles
Time frame: Baseline, 6 weeks
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Matching placebo of LCQ908
Matching placebo of fenofibrate
Matching placebo of fish oil capsule
Novartis Investigative Site
Muscle Shoals, Alabama, United States
Novartis Investigative Site
Glendale, Arizona, United States
Novartis Investigative Site
Encinitas, California, United States
Novartis Investigative Site
Colorado Springs, Colorado, United States
Novartis Investigative Site
Brandon, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Ocala, Florida, United States
Novartis Investigative Site
Orange City, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
...and 22 more locations