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Also known as 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...
NPM-139 is an investigational subcutaneous implant formulation of semaglutide being developed by Vivani Medical, Inc. for the treatment of obesity and overweight. It is designed to deliver semaglutide, a GLP-1 receptor agonist, from a small implant placed under the skin. It is currently in Phase 1 clinical development.
NPM-139 is being developed for obesity and overweight in adults. The Phase 1 program is evaluating the implant in this metabolic indication. Because it remains investigational, NPM-139 has not been approved for any use, and its safety and efficacy in obesity have not been established.
NPM-139 targets GLP1R, the glucagon-like peptide-1 receptor, and acts as a receptor agonist. Semaglutide, the active agent released by the implant, activates GLP1R. Vivani Medical is developing the implant formulation to provide sustained delivery of semaglutide from a subcutaneous depot rather than through regular injections.
NPM-139 is being developed by Vivani Medical, Inc., which trades on the Nasdaq under the ticker VANI. The company is advancing the subcutaneous semaglutide implant as part of its metabolic pipeline, with the obesity and overweight program currently in Phase 1 testing.
NPM-139 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single registered trial is a Phase 1 study of a subcutaneous semaglutide implant, and it has not yet begun recruiting participants.
NPM-139 is being studied in one Phase 1 trial, NCT07430059, titled Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant. The study is not yet recruiting, plans to enroll 20 adults aged 18 years and older, and uses an active-controlled, randomized design without blinding in obesity and overweight.
NPM-139 is an implant formulation of semaglutide, so it is also referred to as Semaglutide Implant (NPM-139) and by semaglutide-related names such as Semaglutide 1.0 mg/mL. The active agent is semaglutide; NPM-139 refers specifically to Vivani Medical's subcutaneous implant version rather than to other semaglutide products.