Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.

Official Title
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Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Icosapent


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 (DAPT). Participants taking direct oral anticoagulants (DOAC) or warfarin.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MND-2119 2g<br>MND-2119 2 g, orally, once daily after breakfast for 52 weeks. | Drug: Icosapent<br>* Icosapent (MND-2119) capsules.<br>|
| Experimental: MND-2119 4g<br>MND-2119 4 g, orally, once daily after breakfast for 52 weeks. | Drug: Icosapent<br>* Icosapent (MND-2119) capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions (ADRs) |  | 52 Weeks | 
| Actual Value and Percent Change From Baseline in Triglyceride |  | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Actual Value and Percent Change From Baseline in Total Cholesterol |  | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) |  | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) |  | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) |  | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |