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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03693131

Enrollment

580

Registered

2018-10-02

Start date

2018-10-27

Completion date

2019-06-29

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGIcosapent (MND-2119)

Icosapent (MND-2119) capsules.

DRUGIcosapent (EPADEL CAPSULES 300)

Icosapent (EPADEL CAPSULES 300) capsules.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

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.

Design outcomes

Primary

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

Measure	Time frame
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
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026