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Also known as GFT505- new formulation, elafibranor
GFT505 · 8 trials · 13 indications
Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.
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)
In participants with end stage renal disease compared to healthy volunteers
In participants with end stage renal disease compared to healthy volunteers
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 80 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 120 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| 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. |
| Matching placebo | PLACEBO_COMPARATOR | - |
| End Stage Renal Disease | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Healthy | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Mild Child-Pugh A | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Moderate Child-Pugh B | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Severe Child-Pugh C | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Name | Type | Description |
|---|---|---|
| Elafibranor 80 mg | DRUG | Two coated tablets daily for 12 weeks |
| Elafibranor 120 mg | DRUG | Two coated tablets daily for 12 weeks |
| Placebo | DRUG | Two coated tablets daily for 12 weeks |
| GFT505 80mg | DRUG | - |
| GFT505 120mg | DRUG | - |
| Elafibranor | DRUG | 120mg oral single dose |
Inclusion Criteria: 1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) * Positive...
GFT505 is an investigational small molecule developed by Genfit SA (ticker GNFT) for metabolic conditions. It has been studied in Phase 2 clinical trials for non-alcoholic steatohepatitis (NASH), atherogenic dyslipidaemia, impaired glucose tolerance, insulin resistance, and type II diabetes mellitus. It is not approved and remains in clinical development.
GFT505 has been studied in Phase 2 trials for non-alcoholic steatohepatitis (NASH), atherogenic dyslipidaemia, impaired glucose tolerance, insulin resistance, and type II diabetes mellitus. These are investigational uses; the drug is not approved for any indication and remains in clinical development.
GFT505 is developed by Genfit SA, which trades under the ticker GNFT as a sponsored ADR. Genfit sponsored the Phase 2 clinical program evaluating GFT505 across metabolic indications including NASH, atherogenic dyslipidaemia, impaired glucose tolerance, insulin resistance, and type II diabetes mellitus.
GFT505 is in Phase 2 development. Its clinical program includes completed Phase 2 trials, among them a Phase IIb study in NASH and pilot studies in impaired glucose tolerance, insulin resistance, and atherogenic dyslipidaemia. The drug is investigational and has not been approved for any indication.
GFT505 has been evaluated in completed Phase 2 trials, including NCT01694849, a Phase IIb placebo-controlled study in NASH that enrolled 275 patients across the United States and Europe, plus pilot studies NCT01275469, NCT01271777, and NCT01271751 in impaired glucose tolerance, insulin resistance, and atherogenic dyslipidaemia.