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Exenatide · 2 trials · 3 indications
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion. Infusion rate adjustment will be done to achieve tolerable infusion rate when nausea/vomiting occurs
AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
| Arm | Type | Description |
|---|---|---|
| Exenatide infusion in Part A | EXPERIMENTAL | Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours. |
| Exenatide infusion in Part B | EXPERIMENTAL | Subjects in Part B will receive exenatide with daily increases in the infusion rate. |
| Name | Type | Description |
|---|---|---|
| Exenatide | DRUG | Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion. |
Inclusion Criteria * Male/females aged between 18 and 60 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-le...
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Exenatide is an investigational small molecule being developed for obesity and type 2 diabetes mellitus. It is in Phase 1 clinical development. The drug is being studied in patients with these metabolic conditions, and it has not been approved by the FDA.
Exenatide is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug for metabolic conditions including obesity and type 2 diabetes mellitus.
Exenatide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing or completed to assess its safety and efficacy in patients with type 2 diabetes mellitus and obesity.
Exenatide has been studied in two Phase 1 trials. NCT00259896 was an in-patient study in patients with type 2 diabetes mellitus, enrolling 30 participants. NCT01857895 was a feasibility study of exenatide by continuous subcutaneous infusion in obesity, enrolling 10 participants in the United States.
Exenatide is the generic name for the drug also known as Byetta, a GLP-1 receptor agonist used for type 2 diabetes. However, the specific formulation under development by GSK plc is an investigational small molecule being studied for obesity and type 2 diabetes mellitus.