MN-001 for Diabetes Mellitus, Type 2

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 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).

Treatment Effectiveness

Trial Safety

Trial Design

Trial Logistics

Closest Location: Jubilee Clinical Research, Inc. · Las Vegas, NV

2021First Recorded Clinical Trial

1 TrialsResearching Diabetes Mellitus, Type 2

6 CompletedClinical Trials

Eligibility Criteria

About The Reviewer

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.