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

• Sponsor: Mochida Pharmaceutical Company, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04221217
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Drug: Icosapent	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
• Actual Study Start Date: Feb 14, 2020
• Actual Primary Completion Date: Jul 14, 2021
• Actual Study Completion Date: Jul 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MND-2119 2g MND-2119 2 g, orally, once daily after breakfast for 52 weeks.	Drug: Icosapent; Icosapent (MND-2119) capsules.
Experimental: MND-2119 4g MND-2119 4 g, orally, once daily after breakfast for 52 weeks.	Drug: Icosapent; Icosapent (MND-2119) capsules.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [52 Weeks]

Secondary Outcome Measures

1. Number of Participants With Adverse Drug Reactions (ADRs) [52 Weeks]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mochida Investigational sites	Tokyo		Japan

Sponsors and Collaborators

• Mochida Pharmaceutical Company, Ltd.

Investigators

• Study Director: Takuya Mori, Mochida Pharmaceutical Company, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mochida Pharmaceutical Company, Ltd.
• ClinicalTrials.gov Identifier: NCT04221217
• Other Study ID Numbers: MND2119H41; JapicCTI
• First Posted: Jan 9, 2020
• Last Update Posted: Aug 23, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertriglyceridemia

Study Results

No Results Posted as of Aug 23, 2021