Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05670379 | Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant | PHASE1 | COMPLETED | 24 | — | — | Dec 20, 2024 | Aug 21, 2025 | Sep 23, 2025 | 1 | Australia |
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 ...