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

Phase 2

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Hypertriglyceridemia
• Interventions: Drug: MN-001 placebo; Drug: MN-001

• Registration Number: NCT05464784
• Lead Sponsor: MediciNova

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Start: 2022-08-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• FibroScan® CAP score ≥ 248 dB/m within 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;
• Weight change >5% within last 3 months of Screening visit;
• Active gastrointestinal disease or history of gastric bypass surgery which could interfere with the absorption of oral medication;
• History of clinically significant acute cardiac event within 6 months of Screening;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MN-001 Placebo	MN-001 placebo	The placebo comparator is a tablet identical in appearance to MN-001.
MN-001	MN-001	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in fasting serum triglyceride levels at Week 24	Week 24
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in lipids	Baseline to Week 24	Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks
Safety and tolerability of MN-001	Baseline to Week 24	Incidence of adverse events, abnormal clinical laboratory results

Trial Locations

Locations (2)

Pinnacle Clinical Research at South Texas Research Institute; 🇺🇸 Edinburg, Texas, United States

Jubilee Clinical Research, Inc.; 🇺🇸 Las Vegas, Nevada, United States