HypertriglyceridemiaPhase 3NCT04221217
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
A Phase 3 study testing Icosapent 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 safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- 14 Feb 2020to 14 Jul 2021
- 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 (DAPT).
- Participants taking direct oral anticoagulants (DOAC) or warfarin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Long-term Study to Evaluate the Safety and Efficacy 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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Icosapent
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcosapentDrug
Icosapent (MND-2119) capsules.
| Study group | Role | What they receive |
|---|---|---|
| MND-2119 2g | Experimental | MND-2119 2 g, orally, once daily after breakfast for 52 weeks. Receives: Drug: Icosapent |
| MND-2119 4g | Experimental | MND-2119 4 g, orally, once daily after breakfast for 52 weeks. Receives: Drug: Icosapent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: 52 Weeks
Secondary outcomes (6)
Number of Participants With Adverse Drug Reactions (ADRs)
Measured: 52 Weeks
Actual Value and Percent Change From Baseline in Triglyceride
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in Total Cholesterol
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start14 Feb 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takuya Mori, Study director, Mochida Pharmaceutical Company, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221217
- Sponsor's protocol ID
- MND2119H41
- Other IDs
- JapicCTI
- Status last verified
- Sep 2020
- First submitted
- 6 Jan 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT04221217
- Acronym / sponsor ID
- MND2119H41
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 9 Jan 2020 (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 safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MND-2119 2g | Experimental | Drug: IcosapentMND-2119 2 g, orally, once daily after breakfast for 52 weeks. |
| MND-2119 4g | Experimental | Drug: IcosapentMND-2119 4 g, orally, once daily after breakfast for 52 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 |
|---|---|---|
| IcosapentIcosapent (MND-2119) capsules. | Drug | MND-2119 2g, MND-2119 4g |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 52 Weeks
6 secondary outcomes
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: 52 Weeks
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
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
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
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
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
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 23 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Hypertriglyceridemia
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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.
Takuya Mori 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 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 23 Aug 2021. 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?
Number of Participants With Adverse Events (AEs) (time frame: 52 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 23 Aug 2021.