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

Launched by MEDICINOVA · Jul 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called MN-001 (tipelukast) to see if it can help patients with non-alcoholic fatty liver disease, type 2 diabetes, and high triglycerides. The trial will involve about 40 participants in the U.S., who will be randomly assigned to take either the medication or a placebo (a harmless sugar pill) for 24 weeks. The main goals are to check if the medication reduces liver fat and lowers triglyceride levels in the blood.

To be eligible for this trial, participants should have specific liver fat measurements and a diagnosis of type 2 diabetes with certain blood sugar levels. They should also have high triglycerides in their blood and have been on stable diabetes medication for at least three months. Throughout the study, participants will be monitored for safety and how well they tolerate the treatment. This trial is currently recruiting participants of all genders, aged between 18 and 75. If you're considering joining, it’s a good opportunity to contribute to research that could help improve treatment options for these conditions.

Gender

ALL

Eligibility 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;