MN-001 for Non-alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of oral antidiabetic therapy for at least 3 months before joining the trial.
How is the drug MN-001 different from other treatments for non-alcoholic fatty liver disease?
What data supports the effectiveness of the drug MN-001 (Tipelukast) for treating non-alcoholic fatty liver disease?
A study on montelukast, a similar drug, showed significant improvement in liver stiffness and liver enzymes in patients with non-alcoholic steatohepatitis (NASH), a more severe form of non-alcoholic fatty liver disease (NAFLD). This suggests that MN-001, which is related to montelukast, might also be effective for NAFLD.16789
Who Is on the Research Team?
Kazuko Matsuda, MD PhD MPH
Principal Investigator
Medicinova Inc
Are You a Good Fit for This Trial?
This trial is for adults with Non-alcoholic Fatty Liver Disease and Type 2 Diabetes who have high triglycerides, are on stable diabetes medication, and show a certain level of liver fat. People can't join if they've had significant weight changes recently, certain gastrointestinal issues or surgeries, advanced liver fibrosis or cirrhosis, recent severe heart events, or other specific liver diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MN-001
- MN-001 placebo
MN-001 is already approved in European Union, Canada for the following indications:
- Scleroderma
- Systemic sclerosis
- Scleroderma
- Systemic sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediciNova
Lead Sponsor