Trials / Completed
CompletedNCT05670379
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Vivani Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Exenatide Implant | 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. |
| DRUG | Bydureon BCise (exenatide extended release) | glucagon-like peptide-1 (GLP-1) receptor agonist |
| DRUG | Semaglutide, 1.0 mg/mL | glucagon-like peptide-1 (GLP-1) receptor agonist |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2025-08-21
- Completion
- 2025-08-21
- First posted
- 2023-01-04
- Last updated
- 2025-09-23
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05670379. Inclusion in this directory is not an endorsement.