Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-9674 · 1 trial · 1 indication
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...
GS-9674 is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH), a metabolic liver condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
GS-9674 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is in Phase 2 clinical trials for nonalcoholic steatohepatitis (NASH).
GS-9674 is in Phase 2 clinical development. It is an investigational drug for nonalcoholic steatohepatitis (NASH) and has not yet been approved by the FDA or other regulatory agencies. Its Phase 2 trial has been completed.
GS-9674 has one completed Phase 2 clinical trial, identified as NCT02854605. This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and efficacy of GS-9674 in 140 participants with nonalcoholic steatohepatitis (NASH) across multiple countries.
GS-9674 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for nonalcoholic steatohepatitis (NASH). The drug has completed a Phase 2 trial but has not yet received regulatory approval.