Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Semaglutide,mL, Semaglutide Implant (NPM-139), Semaglutide
NPM-139 · 1 trial · 1 indication
total semaglutide concentration
Maximal semaglutide concentration
Time to reach maximal semaglutide concentration
Incidence of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Semaglutide Implant (NPM-139) | EXPERIMENTAL | Each participants in this arm will receive one Semaglutide Implant (NPM-139) which will be inserted subcutaneously in the upper outer arm and subsequently removed after 4 weeks of treatment. |
| Semaglutide (Wegovy) weekly injection | ACTIVE_COMPARATOR | Each participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment. |
| Name | Type | Description |
|---|---|---|
| Semaglutide Implant (NPM-139) | COMBINATION_PRODUCT | Semaglutide Implant (NPM-139) is a drug/device combination product consisting of a subdermal titanium implant \~23 mm long and 2 mm in diameter, containing a sterile liquid formulation of semaglutide that is released from the implant at a substantially constant rate over at least 15 weeks. |
| Semaglutide (Wegovy) weekly injection | DRUG | Semaglutide (Wegovy) is a clear, colorless solution provided as Wegovy FlexTouch four-dose pens: 0.25 mg/0.5 mL. It is injected SC in the abdomen, thigh or upper arm once/week. |
Inclusion Criteria: * BMI between 27 and 40 kg/m2 (inclusive) * HbA1c \</= 6.0% and FPG \</+ 6.7 mmil/L * eGFR \>/= 60 mL/m2 * No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination Exclusio...