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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02854605 | Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 140 | — | — | Oct 26, 2016 | Jan 9, 2018 | Jan 29, 2019 | 37 | United States, Canada +4 |
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
| Arm | Type | Description |
|---|---|---|
| GS-9674 30 mg | EXPERIMENTAL | GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
| GS-9674 100 mg | EXPERIMENTAL | GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
| Name | Type | Description |
|---|---|---|
| GS-9674 | DRUG | Tablet administered orally once daily |
| Placebo to match GS-9674 | DRUG | Tablet(s) administered orally once daily |
Key Inclusion Criteria: * Meets the following conditions: * A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) * Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis * Screening magnetic resonance elastography (MRE) with liver stiffn...