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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: No
View:

• MRI-PDFF ≥8 % obtained during the Screening period (baseline MRI-PDFF) or a historic MRI-PDFF ≤8 weeks of randomization.

• Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and ≤10% at Screening.

• Fasting serum triglycerides (TG) at Screening >150 mg/dL

• On a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.

Locations
United States
Nevada
Jubilee Clinical Research, Inc.
Recruiting
Las Vegas
Contact Information
Primary
Study Manager
clinicaltrialinfo@medicinova.com
858-373-1500
Time Frame
Start Date: August 22, 2022
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 40
Treatments
Experimental: MN-001
Placebo Comparator: MN-001 Placebo
The placebo comparator is a tablet identical in appearance to MN-001.
Authors
Elliott Shin
Sponsors
Leads: MediciNova

This content was sourced from clinicaltrials.gov

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