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| Name | Class |
|---|---|
| Avance Clinical Pty Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | Total exenatide concentration | 9 weeks |
| Maximum plasma concentration observed (Cmax) | Maximal exenatide concentration | 9 weeks |
| Time to maximum plasma concentration observed (Tmax) | Time to reach maximal exenatide concentration | 9 weeks |
| Adverse events | Incidence of treatment-emergent adverse events | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Vivani Medical, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMax | Adelaide | Australia |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| C000591245 | semaglutide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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|
| 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 |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |