Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fasiglifam · 1 trial · 1 indication
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks. |
| Fasiglifam 25 mg | EXPERIMENTAL | Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks. |
| Fasiglifam 50 mg | EXPERIMENTAL | Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Fasiglifam placebo-matching tablets |
| Fasiglifam | DRUG | Fasiglifam tablets |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Fasiglifam was developed for the treatment of type 2 diabetes mellitus. It was studied as an oral small molecule therapy intended to improve glycemic control in adults with the condition. The clinical program included a Phase 3 trial in participants with type 2 diabetes.
Fasiglifam targets FFAR1, also known as free fatty acid receptor 1. It acts as a positive allosteric modulator of this receptor. This mechanism was designed to enhance glucose-dependent insulin secretion in patients with type 2 diabetes.
Fasiglifam was developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical trial program for the drug in type 2 diabetes.
Fasiglifam reached Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial has been completed.
Fasiglifam was studied in one Phase 3 clinical trial, NCT01456195, titled Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes. The trial was completed and enrolled 421 participants across the United States, Argentina, Bulgaria, Guatemala, Hungary, Mexico, Slovakia, and Ukraine.
Yes, Fasiglifam is also known as TAK-875. Both names refer to the same investigational drug developed by Takeda for type 2 diabetes.