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

Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04221217

Enrollment

120

Registered

2020-01-09

Start date

2020-02-14

Completion date

2021-07-14

Last updated

2021-08-23

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 safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.

Interventions

DRUGIcosapent

Icosapent (MND-2119) capsules.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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

Design outcomes

Primary

Measure	Time frame
Number of Participants With Adverse Events (AEs)	52 Weeks

Secondary

Measure	Time frame
Actual Value and Percent Change From Baseline in Total Cholesterol	Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Number of Participants With Adverse Drug Reactions (ADRs)	52 Weeks
Actual Value and Percent Change From Baseline in Triglyceride	Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)	Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Countries

Japan

Outcome results

None listed

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