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

August 19, 2021 updated by: Mochida Pharmaceutical Company, Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Mochida Investigational sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: 52 Weeks
52 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)
Time Frame: 52 Weeks
52 Weeks
Actual Value and Percent Change From Baseline in Triglyceride
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 Total Cholesterol
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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)
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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)
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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)
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mochida Pharmaceutical Company, Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

July 14, 2021

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MND2119H41
  • JapicCTI (Registry Identifier: JapicCTI-205100)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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