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

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Icosapent

• Registration Number: NCT04221217
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Study Start: 2020-02-14
• Status Verified: 2020-09
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MND-2119 2g	Icosapent	MND-2119 2 g, orally, once daily after breakfast for 52 weeks.
MND-2119 4g	Icosapent	MND-2119 4 g, orally, once daily after breakfast for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	52 Weeks

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants With Adverse Drug Reactions (ADRs)	52 Weeks
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
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
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

Trial Locations

Locations (1)

Mochida Investigational sites; 🇯🇵 Tokyo, Japan