MN-001 treatment for liver disease, diabetes, and high triglycerides
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
This study is testing if a new treatment called MN-001 can help people with liver disease, diabetes, and high triglycerides feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | MediciNova Industry-sponsored |
| Locations | 2 sites (Las Vegas, Nevada and 1 other locations) |
| Trial ID | NCT05464784 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy of MN-001 (tipelukast) in approximately 40 patients with Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia. Participants will be randomly assigned to receive either 500 mg/day of MN-001 or a placebo for 24 weeks. The primary endpoints include changes in liver fat content and fasting serum triglycerides, measured using a non-invasive FibroScan® technique. Secondary endpoints will assess safety, tolerability, and lipid profile changes.
Who should consider this trial
Good fit: Ideal candidates include adults with Type 2 Diabetes Mellitus, elevated triglycerides, and confirmed liver fat content as measured by FibroScan®.
Not a fit: Patients with other chronic liver diseases, advanced liver fibrosis, or Type 1 Diabetes Mellitus may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver health and metabolic parameters in patients with these conditions.
How similar studies have performed: Previous studies have shown promise in treating similar conditions with novel approaches, but this specific intervention is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Las Vegas, Nevada and 1 other locations
- Jubilee Clinical Research, Inc. — Las Vegas, Nevada, United States (Recruiting)
- Pinnacle Clinical Research at South Texas Research Institute — Edinburg, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Project Management Team
- Email: clinicaltrialinfo@medicinova.com
- Phone: (858) 373-1500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.