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.

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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.

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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.

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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.