HypertriglyceridemiaPhase 3NCT03693131
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
A Phase 3 study testing Icosapent (MND-2119) and Icosapent (EPADEL CAPSULES 300) in people with Hypertriglyceridemia, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Icosapent (MND-2119) and Icosapent (EPADEL CAPSULES 300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteJapan
- Study dates
- 27 Oct 2018to 29 Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with hypertriglyceridemia.
- Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients 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.
Read the detailed description
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Icosapent (MND-2119), Icosapent (EPADEL CAPSULES 300)
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icosapent (MND-2119)Drug
Icosapent (MND-2119) capsules.
Icosapent (EPADEL CAPSULES 300)Drug
Icosapent (EPADEL CAPSULES 300) capsules.
| Study group | Role | What they receive |
|---|---|---|
| MND-2119 2 g | Experimental | MND-2119 2 g, orally, once daily after breakfast for 12 weeks. Receives: Drug: Icosapent (MND-2119) |
| MND-2119 4 g | Experimental | MND-2119 4 g, orally, once daily after breakfast for 12 weeks. Receives: 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. Receives: 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. Receives: Drug: Icosapent (EPADEL CAPSULES 300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start27 Oct 2018
- Primary completion15 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kohichi Hayashi, Study director, Mochida Pharmaceutical Company, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693131
- Sponsor's protocol ID
- MND2119H31
- Other IDs
- JapicCTI-184130
- Status last verified
- Jul 2019
- First submitted
- 30 Sep 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT03693131
- Acronym / sponsor ID
- MND2119H31
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MND-2119 2 g | Experimental | Drug: Icosapent (MND-2119)MND-2119 2 g, orally, once daily after breakfast for 12 weeks. |
| MND-2119 4 g | Experimental | Drug: Icosapent (MND-2119)MND-2119 4 g, orally, once daily after breakfast for 12 weeks. |
| EPADEL CAPSULES 300 1.8 g | Active comparator | Drug: Icosapent (EPADEL CAPSULES 300)EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks. |
| EPADEL CAPSULES 300 2.7 g | Active comparator | Drug: Icosapent (EPADEL CAPSULES 300)EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants diagnosed with hypertriglyceridemia.
- Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icosapent (MND-2119)Icosapent (MND-2119) capsules. | Drug | MND-2119 2 g, MND-2119 4 g |
| Icosapent (EPADEL CAPSULES 300)Icosapent (EPADEL CAPSULES 300) capsules. | Drug | EPADEL CAPSULES 300 1.8 g, EPADEL CAPSULES 300 2.7 g |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kohichi Hayashi study director
Mochida Pharmaceutical Company, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icosapent (MND-2119) and Icosapent (EPADEL CAPSULES 300) in people with Hypertriglyceridemia, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.