Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Mochida Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Icosapent (EPADEL CAPSULES 300); Drug: Icosapent (MND-2119)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03693131

MND2119H31

JapicCTI-184130 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.

Full 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.

Enrollment: 580 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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580 participants in 4 patient groups

MND-2119 2 g

Experimental group

Description:

MND-2119 2 g, orally, once daily after breakfast for 12 weeks.

Treatment:

Drug: Icosapent (MND-2119)

MND-2119 4 g

Experimental group

Description:

MND-2119 4 g, orally, once daily after breakfast for 12 weeks.

Treatment:

Drug: Icosapent (MND-2119)

EPADEL CAPSULES 300 1.8 g

Active Comparator group

Description:

EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.

Treatment:

Drug: Icosapent (EPADEL CAPSULES 300)

EPADEL CAPSULES 300 2.7 g

Active Comparator group

Description:

EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.

Treatment:

Drug: Icosapent (EPADEL CAPSULES 300)