Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2021
CompletedAugust 23, 2021
September 1, 2020
1.4 years
January 6, 2020
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs)
52 Weeks
Secondary Outcomes (6)
Number of Participants With Adverse Drug Reactions (ADRs)
52 Weeks
Actual Value and Percent Change From Baseline in Triglyceride
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
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)
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)
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- +1 more secondary outcomes
Study Arms (2)
MND-2119 2g
EXPERIMENTALMND-2119 2 g, orally, once daily after breakfast for 52 weeks.
MND-2119 4g
EXPERIMENTALMND-2119 4 g, orally, once daily after breakfast for 52 weeks.
Interventions
Eligibility Criteria
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 (DAPT).
- Participants taking direct oral anticoagulants (DOAC) or warfarin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mochida Investigational sites
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takuya Mori
Mochida Pharmaceutical Company, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 9, 2020
Study Start
February 14, 2020
Primary Completion
July 14, 2021
Study Completion
July 14, 2021
Last Updated
August 23, 2021
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share