MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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
MRI Proton Density Fat Fraction (MRI-PDFF) at Week 24, and (2) change from baseline in
fasting serum triglycerides at Week 24. MRI-PDFF 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).