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: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediciNova

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Other causes of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, biopsy-proven cirrhosis, hepatocellular carcinoma);

• Documented history of advanced liver fibrosis

• Evidence of cirrhosis, hepatic decompensation, portal hypertension including splenomegaly, ascites, encephalopathy and/or esophageal varices;

• Diagnosis or history of Diabetes mellitus type 1;