Overweight and Obesity, Type2diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
Interventions
COMBINATION_PRODUCTExenatide 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.
DRUGBydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
glucagon-like peptide-1 (GLP-1) receptor agonist
Sponsors
Avance Clinical Pty Ltd.
Vivani Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | 9 weeks | Total exenatide concentration |
| Maximum plasma concentration observed (Cmax) | 9 weeks | Maximal exenatide concentration |
| Time to maximum plasma concentration observed (Tmax) | 9 weeks | Time to reach maximal exenatide concentration |
| Adverse events | 9 weeks | Incidence of treatment-emergent adverse events |
Countries
Australia
Outcome results
None listed