Efficacy of MND-2119 in Participants With Hypertriglyceridemia

MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia

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.

Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
3. Participants with, or with a history of, pancreatitis.
4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
5. Participants taking both anti-coagulants and anti-platelets.
6. Participants receiving dual antiplatelet therapy.
7. Participants taking direct oral anticoagulants.