MediciNova Reports Positive MN-001 Trial Results for Diabetes and Liver Health
News related to:MediciNova, Inc · 3 min read
LA JOLLA, Calif., Sept. 28, 2026 /CourierPR/ -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the topline results from MN-001-NATG-202, a Phase 2 clinical trial evaluating MN-001 (tipelukast) for the treatment of hypertriglyceridemia and nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus (T2DM). The study involved 40 patients with NAFLD and hypertriglyceridemia associated with T2DM, and the treatment period was 24 weeks.
Key Results: - Serum Triglycerides (TG): At Week 24, the mean serum TG decreased from baseline by 45.8 mg/dL (21.78%) in the MN-001 group and by 14.4 mg/dL (6.97%) in the placebo group. The mean decrease was 31.4 mg/dL greater with MN-001 than with placebo (p=0.113). At Week 4, the mean serum TG decreased from baseline by 54.7 mg/dL (26.05%) in the MN-001 group and by 23.8 mg/dL (11.54%) in the placebo group. The mean decrease was 30.96 mg/dL greater with MN-001 than with placebo, and this difference was statistically significant (p=0.015). - Liver Fat: At Week 24, the mean controlled attenuation parameter (CAP) score measured by FibroScan® decreased from baseline by 14.1 dB/m (4.24%) in the MN-001 group and by 4.3 dB/m (1.27%) in the placebo group. The mean decrease was 9.7 dB/m greater with MN-001 than with placebo; however, this difference was not statistically significant (p=0.2438). - High-Density Lipoprotein Cholesterol (HDL-C): At Week 24, the mean HDL-C increased by 3.3 mg/dL (8.39%) in the MN-001 group but decreased by 2.4 mg/dL (6.23%) in the placebo group. The difference between the MN-001 and placebo groups was 5.7 mg/dL and was statistically significant (p=0.0048). - High-Density Lipoprotein Particle Concentration (HDL-P): At Week 24, the mean HDL-P increased by 3.62 µmol/L (11.80%) in the MN-001 group but decreased by 0.9 µmol/L (3.00%) in the placebo group. The difference between the MN-001 and placebo groups was 4.52 µmol/L and was statistically significant (p=0.018). - Body Weight: At the end of the study, the mean body weight decreased by 4.91 lb (2.28%) in the MN-001 group and by 0.55 lb (0.25%) in the placebo group. The mean decrease in body weight was 4.36 lb greater with MN-001 than with placebo (p=0.082).
MN-001 demonstrated a generally favorable safety and tolerability profile. Treatment-related adverse events were mild to moderate in severity, and no drug-related serious adverse events (SAEs) were reported in the study.
The study demonstrated a statistically significant reduction in serum TG at Week 4 with MN-001 than with placebo. At Week 24, the MN-001 group continued to show a numerical reduction from baseline value, although the difference between the MN-001 and placebo groups were not statistically significant. Statistically significant increases in HDL-C and HDL-P were also observed with the MN-001 group, while liver fat and body weight showed trends toward improvement. Collectively, these exploratory findings suggest that MN-001 may have beneficial effects across several metabolic parameters, including lipid metabolism, body weight, and liver fat.
The changes in TG, HDL-C, and HDL-P were also consistent with findings from preclinical in-vitro mechanism of action studies and previous MN-001-NATG-201 clinical trial. Together with the clinical findings, these results provide a basis for further evaluation of MN-001 in metabolic and cardiovascular diseases.
Next Steps: This was a proof of concept, exploratory study involving 40 patients. Preliminary review of the topline data indicates that efficacy should be evaluated in a larger study. MediciNova will continue detailed analyses of the study data and assess the next stage of clinical development, including the appropriate patient population, endpoints, and sample size.