At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
MN-001drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study To Evaluate The Efficacy, Safety, Tolerability and PK of MN-001 (Tipelukast) on HDL Function and Serum Triglyceride Levels in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD) Subjects With Hypertriglyceridemia
In Brief
A Phase 2 clinical trial evaluating MN-001 for Non-alcoholic Steatohepatitis and 3 related conditions. Completed, enrolled 19 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Steatohepatitis, Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease, Hypercholesterolemia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionMay 2018
Study CompletionOct 2019
TodayJul 2026
First PostedFeb 12, 2016
Enrollment StartMar 1, 2016
Primary CompletionMay 30, 2018
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.4 years ago
Interventions
MN-001drug
MN-001 is a novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory activity