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

NCT05464784 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MN-001-NATG-202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety and tolerability of MN-001

  Baseline to Week 24

• Mean change from baseline in lipids

  Baseline to Week 24

Study Arms (2)

MN-001

EXPERIMENTAL

Drug: MN-001

MN-001 Placebo

PLACEBO COMPARATOR

The placebo comparator is a tablet identical in appearance to MN-001.

Drug: MN-001 placebo

Interventions

MN-001 DRUG

MN-001 is a novel, orally bioavailable small molecule compound

MN-001

MN-001 placebo DRUG

The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.

MN-001 Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MediciNova: lead

Study Sites (2)

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

Location

Pinnacle Clinical Research at South Texas Research Institute

Edinburg, Texas, 78539, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertriglyceridemia; Non-alcoholic Fatty Liver Disease

Interventions

4-(6-acetyl-3-(3-(4-acetyl-3-hydroxy-2-propylphenylthio)propoxy)-2-propylphenoxy)butyric acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 19, 2022
• Study Start: August 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)