Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Auto-injector with exenatide · 1 trial · 1 indication
The primary outcome measure is the number of device-related injection failures of the single-use, pre-filled auto-injector.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 2 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 3 | EXPERIMENTAL | exenatide suspension - 4.5 mg /1.1 mL |
| Arm 4 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.1 mL |
| Arm 5 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.5 mL |
| Name | Type | Description |
|---|---|---|
| Auto-injector with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
| Syringe with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
Inclusion Criteria: * Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent. * Has no significant health issues that would preclude study participation, as determined by medical history and physical examination * Has body mass index of 22 kg/m2 to 45 kg/m2, inclu...
The auto-injector with exenatide is an investigational drug-device combination being developed by AstraZeneca PLC. It pairs the compound exenatide with an auto-injector delivery device. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of the auto-injector with exenatide. The company is responsible for the clinical development program for this drug-device combination.
The auto-injector with exenatide is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has one completed Phase 1 trial and no active trials at this time.
The auto-injector with exenatide has been studied in one completed Phase 1 trial, NCT02349802, titled Autoinjector Device Assessment Study. It enrolled 3,052 healthy volunteers aged 18 and older in the United States. The trial was randomized and controlled, with a non-double-blind design.