NCT05464784 · ClinicalTrials.gov record · last posted 2026-02-05
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
StatusActive, Not Recruiting
PhasePhase 2
Started2022-08-22
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from the ClinicalTrials.gov record
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).
Amendment record
6 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 6 times since 2022-07-15; most recent amendment 2026-02-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2026-02-03
Status change Recruiting→Active, Not Recruitingv6
2022-08-24
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT05464784 |
| Lead Sponsor |
MediciNova
|
| Conditions |
Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease |
| Enrollment |
40 participants |
| Start Date |
2022-08-22 |
| Primary Completion |
2026-12-31 (estimated) |
| Study Completion |
2026-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2026-02-05 |