Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Icosapent (MND-2119); Drug: Icosapent (EPADEL CAPSULES 300)

• Registration Number: NCT03693131
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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 Timeline

• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-09-30
• Study First Posted: 2018-10-02
• Study Start: 2018-10-27
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MND-2119 4 g	Icosapent (MND-2119)	MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
MND-2119 2 g	Icosapent (MND-2119)	MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
EPADEL CAPSULES 300 1.8 g	Icosapent (EPADEL CAPSULES 300)	EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
EPADEL CAPSULES 300 2.7 g	Icosapent (EPADEL CAPSULES 300)	EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mochida Investigational sites; 🇯🇵 Tokyo, Japan