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

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. FebroScan 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).

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Hypertriglyceridemia; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: MN-001; Drug: MN-001 placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matsuda; Phone Number: (858) 373-1500; Email: clinicaltrialinfo@medicinova.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Recruiting
      • Jubilee Clinical Research, Inc.
      • Contact: Matthew O'Sullivan, M.A.; Phone Number: 702-631-5000; Email: mosullivan@jcr-lv.com
      • Principal Investigator: Elliott Shin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MN-001	Drug: MN-001; MN-001 is a novel, orally bioavailable small molecule compound
Placebo Comparator: MN-001 Placebo; The placebo comparator is a tablet identical in appearance to MN-001.	Drug: MN-001 placebo; The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MediciNova
• Investigators: Study Director: Kazuko Matsuda, MD PhD MPH, Medicinova Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypertriglyceridemia
• Other Study ID Numbers: MN-001-NATG-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No