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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05464784
The ClinicalTrials.gov registry entry for NCT05464784 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is MediciNova, which has 17 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.