A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Vivani Medical, Inc
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •History of Type 1 or Type 2 Diabetes
- •History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL
- •Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II
- •Current or past exposure to exenatide
Arms & Interventions
Exenatide Implant
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.
Intervention: Exenatide Implant (Combination Product)
Bydureon BCise (exenatide extended release)
2 mg subcutaneous injection every week for a duration of 9 weeks
Intervention: Bydureon BCise (exenatide extended release) (Drug)
Semaglutide
1.0 mg subcutaneous injection every week for a duration of 9 weeks
Intervention: Semaglutide, 1.0 mg/mL (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: 9 weeks
Incidence of treatment-emergent adverse events
Area under the plasma concentration-time curve (AUC)
Time Frame: 9 weeks
Total exenatide concentration
Maximum plasma concentration observed (Cmax)
Time Frame: 9 weeks
Maximal exenatide concentration
Time to maximum plasma concentration observed (Tmax)
Time Frame: 9 weeks
Time to reach maximal exenatide concentration
Secondary Outcomes
No secondary outcomes reported