Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GFT505
elafibranor · 9 trials · 15 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 Healthy Young Adults compared to Healthy Elderly
In Healthy Young Adults compared to Healthy Elderly
In Healthy Young Adults compared to Healthy Elderly
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 | - |
| Young Adults | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| Elderly | EXPERIMENTAL | Single oral dose of elafibranor 120mg |
| 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 | elafibranor 120mg is a coated tablet for oral administration |
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...
Elafibranor is an investigational small molecule drug developed by Genfit SA (ticker GNFT). It has been studied in clinical trials for primary biliary cholangitis (PBC), a liver disease, as well as in pharmacokinetic studies involving elderly volunteers and patients with kidney or liver impairment.
Elafibranor has been evaluated in a Phase 2 clinical trial for patients with primary biliary cholangitis (PBC) who had an inadequate response to ursodeoxycholic acid. The study assessed the efficacy and safety of the drug in this patient population.
Elafibranor targets PPARA and PPARD, where it acts as an agonist. By activating these receptors, elafibranor modulates gene expression involved in lipid metabolism and inflammation, which are relevant pathways in liver and metabolic diseases.
Elafibranor is developed by Genfit SA, which trades under the ticker GNFT as a sponsored ADR. Genfit is a biopharmaceutical company focused on liver and metabolic diseases.
Elafibranor is in Phase 1 of clinical development according to the available data. It is an investigational drug and has not been approved by the FDA for any indication.
Elafibranor has been studied in several completed clinical trials, including NCT04171752 in elderly healthy volunteers, NCT03844555 in patients with renal impairment, NCT03765671 in patients with hepatic impairment, and NCT03124108 in patients with primary biliary cholangitis (PBC).