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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Icosapent (MND-2119); Drug: Icosapent (EPADEL CAPSULES 300)

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: Interventional
• Enrollment (Actual): 580
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Mochida Investigational sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mochida Pharmaceutical Company, Ltd.
• Investigators: Study Director: Kohichi Hayashi, Mochida Pharmaceutical Company, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 29, 2019

Study Registration Dates

• First Submitted: September 30, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia; Platelet Aggregation Inhibitors; Lipid Regulating Agents; Eicosapentaenoic acid ethyl ester
• Other Study ID Numbers: MND2119H31; JapicCTI-184130 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No