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NCT05464784 · ClinicalTrials.gov registry record · Phase 2
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
A Phase 2 study of Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, sponsored by MediciNova.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT05464784: Active Phase 2 study of Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, sponsored by MediciNova.
NCT05464784 is a Phase 2 study of Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease that is active but no longer recruiting, run by MediciNova. The registered enrollment target is 40 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05464784, a Phase 2 study of Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, is active but no longer recruiting, sponsored by MediciNova.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
The design of the Phase 2 clinical trial includes the following elements: * Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S. * Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks. * The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FibroScan® is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response. * Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).
Conditions Studied
Interventions
- DRUG MN-001
- DRUG MN-001 placebo
Study Locations (2)
Nevada
- Jubilee Clinical Research, Inc. - Las Vegas
Texas
- Pinnacle Clinical Research at South Texas Research Institute - Edinburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT05464784 still lists
NCT05464784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which MN-001 is the first listed.
NCT05464784 reports a single indexed study location in Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT05464784 about?
NCT05464784 is a clinical study titled "MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia". The design of the Phase 2 clinical trial includes the following elements: * Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S. * Patients will be randomized 1:1 to receive either 500 mg/day o...
What is the current status of trial NCT05464784?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-08-22. Estimated completion is 2026-12-31.
What conditions does trial NCT05464784 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Hypertriglyceridemia.
What interventions are being tested in trial NCT05464784?
The interventions under investigation include: MN-001 (DRUG), MN-001 placebo (DRUG).
Who is sponsoring clinical trial NCT05464784?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464784 being conducted?
This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05464784's enrollment target sits among peer trials
40 279th of 348 higher than 66 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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