The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia. The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
580
Icosapent (MND-2119) capsules.
Icosapent (EPADEL CAPSULES 300) capsules.
Mochida Investigational sites
Tokyo, Japan
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) (direct method) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
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