Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.

Detailed Description
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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.

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

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Icosapent (MND-2119)
* Drug: Icosapent (EPADEL CAPSULES 300)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed with hypertriglyceridemia. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL. Exclusion Criteria: Participants who have confirmed myocardial infarction and angina pectoris within 6 months. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months. Participants with, or with a history of, pancreatitis. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months. Participants taking both anti-coagulants and anti-platelets. Participants receiving dual antiplatelet therapy. Participants taking direct oral anticoagulants.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MND-2119 2 g<br>MND-2119 2 g, orally, once daily after breakfast for 12 weeks. | Drug: Icosapent (MND-2119)<br>* Icosapent (MND-2119) capsules.<br>|
| Experimental: MND-2119 4 g<br>MND-2119 4 g, orally, once daily after breakfast for 12 weeks. | Drug: Icosapent (MND-2119)<br>* Icosapent (MND-2119) capsules.<br>|
| Active Comparator: EPADEL CAPSULES 300 1.8 g<br>EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks. | Drug: Icosapent (EPADEL CAPSULES 300)<br>* Icosapent (EPADEL CAPSULES 300) capsules.<br>|
| Active Comparator: EPADEL CAPSULES 300 2.7 g<br>EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks. | Drug: Icosapent (EPADEL CAPSULES 300)<br>* Icosapent (EPADEL CAPSULES 300) capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration |  | 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 |  | 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 |  | 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 |  | 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 |  | Baseline and 12 weeks |