Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Icosapent (MND-2119)
Icosapent (MND-2119) capsules.
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) capsules.

Study Arms

Experimental: MND-2119 2 g
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Experimental: MND-2119 4 g
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Active Comparator: EPADEL CAPSULES 300 1.8 g
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
Active Comparator: EPADEL CAPSULES 300 2.7 g
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

580

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2019

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Mochida Pharmaceutical Company, Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Kazuki Furuno Mochida Pharmaceutical Company, Ltd.

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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