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Completed

NCT Number: NCT04221217

Long-term Safety and Efficacy Study 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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mochida Investigational sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants diagnosed with hypertriglyceridemia.
  • Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion criteria

  • Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
  • Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
  • Participants with, or with a history of, pancreatitis.
  • Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
  • Participants taking both anti-coagulants and anti-platelets.
  • Participants receiving dual antiplatelet therapy (DAPT).
  • Participants taking direct oral anticoagulants (DOAC) or warfarin.

Treatment and study plan

Icosapent

Drug

Icosapent (MND-2119) capsules.

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 52 Weeks

Secondary outcomes

  1. Number of Participants With Adverse Drug Reactions (ADRs)

    Time frame: 52 Weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2020
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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