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Completed

NCT Number: NCT03693131

Efficacy of MND-2119 in Participants With Hypertriglyceridemia

The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants 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

About this study

MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.

The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.

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.
  • Participants taking direct oral anticoagulants.

Treatment and study plan

Icosapent (MND-2119)

Drug

Icosapent (MND-2119) capsules.

Icosapent (EPADEL CAPSULES 300)

Drug

Icosapent (EPADEL CAPSULES 300) capsules.

Primary outcomes

  1. Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

  2. Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) (direct method) level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

  3. Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

  4. Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

  5. Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Registry information

Official study title

MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
Aug 1, 2019

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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