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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03421431 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis | PHASE2 | COMPLETED | 134 | — | — | Apr 25, 2018 | Jul 10, 2019 | Sep 16, 2021 | 82 | United States, Canada +4 |
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
| Arm | Type | Description |
|---|---|---|
| EDP-305 Dose 1 | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 Dose 2 | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects will take 2 tablets once a day orally for 12 weeks |
| Name | Type | Description |
|---|---|---|
| EDP-305 Dose 1 | DRUG | Two tablets daily for 12 weeks |
| EDP-305 Dose 2 | DRUG | Two tablets daily for 12 weeks |
| Placebo | DRUG | Two tablets daily for 12 weeks |
Inclusion Criteria: * An informed consent document must be signed and dated by the subject * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive * Male or female with presence of NASH by: * Histologic evidence on a historical liver biopsy within 24 months...