Efficacy of MND-2119 in Participants With Hypertriglyceridemia
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MND-2119 2 g MND-2119 2 g, orally, once daily after breakfast for 12 weeks. |
Drug: Icosapent (MND-2119)
Icosapent (MND-2119) capsules.
|
| Experimental: MND-2119 4 g MND-2119 4 g, orally, once daily after breakfast for 12 weeks. |
Drug: Icosapent (MND-2119)
Icosapent (MND-2119) capsules.
|
| Active Comparator: EPADEL CAPSULES 300 1.8 g EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks. |
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) capsules.
|
| Active Comparator: EPADEL CAPSULES 300 2.7 g EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks. |
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) capsules.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mochida Investigational sites | Tokyo | Japan |
Sponsors and Collaborators
- Mochida Pharmaceutical Company, Ltd.
Investigators
- Study Director: Kohichi Hayashi, Mochida Pharmaceutical Company, Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MND2119H31
- JapicCTI-184130