Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
Summary
This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-05-30
- Completion
- 2019-10-01
Outcome
Met primary endpoint
release “MN-001 (tipelukast) significantly reduced mean serum triglycerides, a primary endpoint, during the study.” medicinova.com ↗
release “MN-001 (tipelukast) significantly reduced mean serum triglycerides, a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment (p=0.00006).” medicinova.com ↗
release “In the first Phase 2 trial, MN-001 demonstrated a statistically significant reduction in the primary endpoint, mean serum triglycerides (p=.02).” medicinova.com ↗
release “In the first Phase 2 trial, MN-001 (tipelukast) demonstrated a statistically significant reduction in the primary endpoint of mean serum triglycerides (p=.02).” medicinova.com ↗
release “In the completed Phase 2 study, MN-001 (tipelukast) significantly reduced serum triglycerides in participants with non-alcoholic fatty liver disease (NAFLD) and hypertriglyceridemia (HTG).” medicinova.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tipelukast | Small molecule | — | Oral |