Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GFT505 · 6 trials · 7 indications
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
To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.
To evaluate after 12 weeks of oral administration of double blind treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).
To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.
To evaluate the efficacy of GFT505 80mg in reducing serum TG compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
To evaluate the efficacy of GFT505 80mg in increasing HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
To evaluate the safety and tolerability of two dose levels of GFT505 (300 and 360 mg), after multiple dose administration once daily for 14 days in male healthy subjects in order to determine the supra-therapeutic dose to be administered in Study Part II.
To evaluate the impact on QTcF of two dose levels (one therapeutic and one supra-therapeutic according to ICH E14) of GFT505, after multiple dose administration once daily for 14 days in healthy male and female subjects compared to placebo and a positive control.
| 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. |
| Matching placebo | PLACEBO_COMPARATOR | - |
| Placebo (Study Part I) | PLACEBO_COMPARATOR | Hard gelatin capsules, oral administration, 5 or 6 capsules per day before breakfast with a glass of water |
| GFT505 300 mg (Study Part I) | EXPERIMENTAL | Hard gelatin capsules dosed at 60mg, oral administration, 5 capsules per day before breakfast with a glass of water |
| GFT505 360 mg (Study Part I) | EXPERIMENTAL | Hard gelatin capsules dosed at 60mg, oral administration, 6 capsules per day before breakfast with a glass of water |
| Placebo (Study Part II) | PLACEBO_COMPARATOR | Hard gelatin capsules, oral administration, 4 to 6 capsules per day before breakfast with a glass of water |
| GFT505 120 mg (Study Part II) | EXPERIMENTAL | Hard gelatin capsules dosed at 60mg, oral administration, 2 capsules per day plus 2 to 4 capsules of placebo per day before breakfast with a glass of water |
| GFT505 xx mg (Study Part II) | EXPERIMENTAL | Supra-therapeutic dose: hard gelatin capsules dosed at 60mg, oral administration, 4 to 6 capsules per day before breakfast with a glass of water |
| Moxifloxacin 400 mg (Study Part II) | ACTIVE_COMPARATOR | On days 1 to 13, 4 to 6 placebo capsules per day, then one 400 mg moxifloxacin tablet (Izilox®, Bayer Pharmaceuticals Corporation) administered orally on Day 14 |
| Name | Type | Description |
|---|---|---|
| GFT505 80mg | DRUG | - |
| GFT505 120mg | DRUG | - |
| Placebo | DRUG | - |
| GFT505 | DRUG | - |
| Moxifloxacin 400 mg | 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...