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CompletedNCT04221217Updated Aug 23, 2021

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

A Phase 3 interventional study of Icosapent in Hypertriglyceridemia, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-08-23.

Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

03

In context

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

This study's enrollment of 120 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 hemorrhagic disease within 6 months.
  5. Participants taking both anti-coagulants and anti-.
  6. Participants receiving dual antiplatelet therapy (DAPT).
  7. Participants taking direct oral anticoagulants (DOAC) or warfarin.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    MND-2119 2g

    MND-2119 2 g, orally, once daily after breakfast for 52 weeks.

    Drug: Icosapent

  • Experimental
    MND-2119 4g

    MND-2119 4 g, orally, once daily after breakfast for 52 weeks.

    Drug: Icosapent

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Mochida Investigational sites
    Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Jul 2021, 17 months.

Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's 17 months is below that.

Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2020
First posted
Jan 9, 2020
StartActual
Feb 14, 2020
Primary completionActual
Jul 14, 2021
CompletionActual
Jul 14, 2021
Last update
Aug 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04221217
Lead sponsor
Mochida Pharmaceutical Company, Ltd.
Responsible party
Sponsor
First posted
Jan 9, 2020
Start date
Feb 14, 2020
Primary completion
Jul 14, 2021
Completion
Jul 14, 2021
Last update
Aug 23, 2021

Study contacts

Takuya Mori
study director · Mochida Pharmaceutical Company, Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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