NCT05464784

MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: MediciNova · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Diabetes Mellitus, Type 2
• Hypertriglyceridemia
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	MN-001	MN-001 is a novel, orally bioavailable small molecule compound
DRUG	MN-001 placebo	The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.

Timeline

• Start date: 2022-08-22
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-07-19
• Last updated: 2026-02-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study