NCT07430059

Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vivani Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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..

Detailed description

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: * Group 1: Semaglutide Implant (NPM-139) * Group 2: Semaglutide 0.25 mg SC once weekly All participants will be domiciled for at least 48 hours following insertion of the implant (Group 1) or first dose of semaglutide 0.25 mg (Group 2). 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.

Conditions

• Obesity & Overweight

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Semaglutide Implant (NPM-139)	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.
DRUG	Semaglutide (Wegovy) weekly injection	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-02-24
• Last updated: 2026-02-24