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Also known as Exenatide Implant
Exenatide · 1 trial · 2 indications
Total exenatide concentration
Maximal exenatide concentration
Time to reach maximal exenatide concentration
Incidence of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Exenatide Implant | EXPERIMENTAL | One Exenatide Implant that delivers approximately 52 microgram/day of exenatide will be inserted subdermally just under the skin of the upper outer arm for the 9-week treatment period. |
| Bydureon BCise (exenatide extended release) | ACTIVE_COMPARATOR | 2 mg subcutaneous injection every week for a duration of 9 weeks |
| Semaglutide | ACTIVE_COMPARATOR | 1.0 mg subcutaneous injection every week for a duration of 9 weeks |
| Name | Type | Description |
|---|---|---|
| Exenatide Implant | COMBINATION_PRODUCT | Exenatide Implant is a drug:device combination that delivers steady levels of exenatide, a glucagon-like peptide-1(GLP-1) receptor agonist, for an extended period of time following subdermal insertion. |
| Bydureon BCise (exenatide extended release) | DRUG | glucagon-like peptide-1 (GLP-1) receptor agonist |
| Semaglutide, 1.0 mg/mL | DRUG | glucagon-like peptide-1 (GLP-1) receptor agonist |
Inclusion Criteria: * BMI 27 to 40 kg/m\^2 * Estimated glomerular filtration rate (eGFR) \>/= 90 mL/min/1.73 m\^2 * HbA1c \< 6.0% and FPG \< 6.7 mol/L Exclusion Criteria: * Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being ...
Exenatide is being developed for overweight and obesity. It is an investigational long-acting implant formulation studied in a Phase 1 trial that enrolled adults with overweight and obesity, including some with type 2 diabetes. It is not yet approved for this use.
Exenatide targets GLP1R, the glucagon-like peptide-1 receptor, and acts as a receptor agonist. By activating GLP1R, it mimics the incretin hormone GLP-1, which is involved in glucose-dependent insulin secretion and appetite regulation.
Vivani Medical, Inc. (ticker VANI) is developing the Exenatide implant. The company is the sponsor of the clinical program evaluating this long-acting formulation for overweight and obesity.
Exenatide is in Phase 1 development. The single Phase 1 trial of the Exenatide implant has been completed, and no active trials are currently listed. It remains an investigational product and has not been approved by the FDA.
Exenatide has been studied in one completed Phase 1 trial, NCT05670379, titled Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant. It was an active-controlled, randomized study that enrolled 24 adults in Australia, including healthy volunteers.
Yes. Exenatide Implant is an alternative name for Exenatide as developed by Vivani Medical. Both names refer to the same long-acting implant formulation being studied for overweight and obesity.