NCT03693131

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

October 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

September 30, 2018

Last Update Submit

July 30, 2019

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 12 weeks

Secondary Outcomes (5)

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

    Baseline and 12 weeks

  • 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

    Baseline and 12 weeks

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

    Baseline and 12 weeks

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

    Baseline and 12 weeks

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

    Baseline and 12 weeks

Study Arms (4)

MND-2119 2 g

EXPERIMENTAL

MND-2119 2 g, orally, once daily after breakfast for 12 weeks.

Drug: Icosapent (MND-2119)

MND-2119 4 g

EXPERIMENTAL

MND-2119 4 g, orally, once daily after breakfast for 12 weeks.

Drug: Icosapent (MND-2119)

EPADEL CAPSULES 300 1.8 g

ACTIVE COMPARATOR

EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.

Drug: Icosapent (EPADEL CAPSULES 300)

EPADEL CAPSULES 300 2.7 g

ACTIVE COMPARATOR

EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.

Drug: Icosapent (EPADEL CAPSULES 300)

Interventions

Icosapent (MND-2119)DRUG

Icosapent (MND-2119) capsules.

MND-2119 2 gMND-2119 4 g
Icosapent (EPADEL CAPSULES 300)DRUG

Icosapent (EPADEL CAPSULES 300) capsules.

EPADEL CAPSULES 300 1.8 gEPADEL CAPSULES 300 2.7 g

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mochida Investigational sites

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Eicosapentaenoic Acideicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Kohichi Hayashi

    Mochida Pharmaceutical Company, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 2, 2018

Study Start

October 27, 2018

Primary Completion

June 15, 2019

Study Completion

June 29, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)