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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02927314 | A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease | PHASE2 | COMPLETED | 60 | — | — | Nov 27, 2017 | Mar 1, 2020 | Mar 17, 2020 | 3 | Israel |
Mean percent change in serum alanine aminotransferase (ALT) levels
Percent change from Baseline in hepatic steatosis measured by magnetic resonance imaging-determined proton-density fat-fraction (MRI-PDFF)
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo tablets orally q12h |
| CF102 12.5mg | ACTIVE_COMPARATOR | CF102 tablets orally q12h |
| CF102 25mg | ACTIVE_COMPARATOR | CF102 tablets orally q12h |
| Name | Type | Description |
|---|---|---|
| CF102 | DRUG | orally q12h |
| Placebo | DRUG | orally q12h |
Inclusion Criteria: 1. At least 18 years of age. 2. Diagnosis of NAFLD by non-invasive determination of liver triglyceride concentration, as defined as triglyceride concentration ≥10.0% by NMRS. 3. At least 2 of the following: * Obesity, defined as body mass index (BMI) of ≥25 and ≤40 kg/m2; or...