MediciNova has commenced a Phase II clinical trial of MN-001 (tipelukast) to treat non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes mellitus (T2DM), and hypertriglyceridemia.
The randomised, placebo-controlled, multi-centre, double-blind Phase II trial has been designed to assess MN-001’s safety and efficacy to treat NAFLD patients with T2DM, and hypertriglyceridemia.
Nearly 40 male and female participants aged 21 to 75 years will be recruited in the US for the study.
In the trial, the participants will be randomised into 1:1 ratio and given either MN-001 (tipelukast) 500 mg/day or placebo for 24 weeks.
The change in liver fat content measured by MRI Proton Density Fat Fraction (MRI-PDFF) as well as change in fasting serum triglycerides from baseline at week 24 will be the trial’s co-primary endpoints.
MediciNova stated that MRI-PDFF is a non-invasive, quantitative, and accurate measurement of liver fat content that is commonly used in early phase trials for measuring the treatment response.
The new orally bioavailable small molecule compound, MN-001 exerts its effects through several mechanisms for producing its anti-inflammatory and anti-fibrotic activity in preclinical models.
MediciNova chief medical officer Kazuko Matsuda said: “MN-001 appears to reduce serum lipid profiles in patients with a dual diagnosis of NAFLD and T2DM/prediabetes with dyslipidemia.
“The efficacy and safety data from this trial, if successful, could lead to a pivotal Phase III trial intended to support an NDA for MN-001 to treat dyslipidemia and reduce liver fat content in patients with NAFLD with T2DM/prediabetes.”
Safety and tolerability along with changes in lipid profile (HDL-C, LDL-C, and total cholesterol) will be some of the secondary endpoints of the trial.
In 2020, MediciNova and ClinCapture formed a strategic collaboration for Covid-19 research.