Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia

Mochida Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Icosapent

Study type: Interventional

Funder types: Industry

Identifiers

NCT04221217

JapicCTI (Registry Identifier)

MND2119H41

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.

Enrollment: 120 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 (DAPT).
7. Participants taking direct oral anticoagulants (DOAC) or warfarin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

MND-2119 2g

Experimental group

Description:

MND-2119 2 g, orally, once daily after breakfast for 52 weeks.

Treatment:

Drug: Icosapent

MND-2119 4g

Experimental group

Description:

MND-2119 4 g, orally, once daily after breakfast for 52 weeks.

Treatment:

Drug: Icosapent