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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01694849 | Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 275 | — | — | Sep 1, 2012 | Dec 1, 2015 | Nov 3, 2022 | 56 | United States, Belgium +7 |
Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as: * Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy * Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy
| Arm | Type | Description |
|---|---|---|
| GFT505 80mg | EXPERIMENTAL | Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water. |
| GFT505 120mg | EXPERIMENTAL | Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water. |
| Placebo | PLACEBO_COMPARATOR | hard gelatin capsules, oral administration, 3 capsules per day before breakfast with a glass of water. |
| Name | Type | Description |
|---|---|---|
| GFT505 80mg | DRUG | - |
| GFT505 120mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Males or females (females must be either of non-child bearing potential or using an efficient double contraception). For male participants, contraceptive measures must be taken during the study, either by the male participant or his female partner. * Body Mass Index ≤ 45 kg/m²...