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NCT Number: NCT05464784

MN-001 in 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. 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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Digestive System Diseases Dyslipidemias Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Non-Alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jubilee Clinical Research, Inc., Las Vegas, Nevada, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

MN-001

Drug

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

MN-001 placebo

Drug

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

Primary outcomes

  1. Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24

    Time frame: Week 24

  2. Mean change from baseline in fasting serum triglyceride levels at Week 24

    Time frame: Week 24

Secondary outcomes

  1. Safety and tolerability of MN-001

    Time frame: Baseline to Week 24

    Incidence of adverse events, abnormal clinical laboratory results

  2. Mean change from baseline in lipids

    Time frame: Baseline to Week 24

    Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks

Sponsors and collaborators

Lead sponsor

MediciNova

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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