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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
MN-001 is a novel, orally bioavailable small molecule compound
The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Pinnacle Clinical Research at South Texas Research Institute
Edinburg, Texas, United States
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Time frame: Week 24
Mean change from baseline in fasting serum triglyceride levels at Week 24
Time frame: Week 24
Safety and tolerability of MN-001
Incidence of adverse events, abnormal clinical laboratory results
Time frame: Baseline to Week 24
Mean change from baseline in lipids
Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks
Time frame: Baseline to Week 24
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