Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02681055 | Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects | PHASE2 | COMPLETED | 19 | — | — | Mar 1, 2016 | Oct 1, 2019 | Mar 15, 2023 | 3 | United States |
Change from baseline to 12 weeks of MN-001 on Cholesterol Efflux Capacity (CEC) in NAFLD subjects with hypertriglyceridemia. CEC, a key step in reverse cholesterol transport, was inversely associated with the incidence of cardiovascular events and is considered to be a new biomarker to assess cardiovascular risk. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool. The ability of serum HDL to remove cholesterol from cultured cells was assessed as an in vitro method to evaluate functional changes in HDL mediated by changes due to MN-001 treatment.
Change from baseline to 8 weeks of MN-001 on serum triglyceride levels in NASH subjects with hypertriglyceridemia
| Arm | Type | Description |
|---|---|---|
| open label arm | EXPERIMENTAL | All 40 subjects will receive MN-001 for the first 4 weeks. At Week 4 subjects will increase their dosage frequency for remaining 8 weeks. Subjects will receive MN-001 for a total of 12 weeks. |
| Name | Type | Description |
|---|---|---|
| MN-001 | DRUG | MN-001 is a novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory activity |
INCLUSION CRITERIA: * Written informed consent is obtained and willing and able to comply with the protocol in the opinion of the Investigator. * Male or female subjects ≥ 18 years of age * Histologically proven NASH (NAFLD activity score of 3 or greater with at least 1 point being ballooning) base...