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| Name | Class |
|---|---|
| Avance Clinical Pty Ltd. | INDUSTRY |
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The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants who are otherwise healthy..
This open label, randomized, parallel-group study will evaluate participants with a body mass index (BMI) between 27 and 40 kg/m2 (inclusive). Safety, tolerability and PK data will be collected and evaluated for the 4-week treatment period. Participants will undergo a Screening Visit and those who meet eligibility will be randomized (1:1) to one of 2 study groups:
Subsequently, participants will return to the clinic weekly until study end. At each of these visits, participants will have blood samples drawn for PK. After sample collections, site staff will administer semaglutide injections to participants in Group 2.
After 4 weeks of treatment (end of study), final PK samples will be collected and participants with implants will undergo a brief implant removal procedure under local anesthetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | total semaglutide concentration | 4 weeks |
| Maximum plasma concentration (Cmax) | Maximal semaglutide concentration | 4 weeks |
| Time to maximum semaglutide concentration (Tmax) | Time to reach maximal semaglutide concentration | 4 weeks |
| Adverse Events | Incidence of treatment-emergent adverse events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer, MD | Contact | 4155068462 | clinical@vivanai.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Vivani Medical, Inc | Study Director |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| 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. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |