Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

NCT07430059 · Not yet recruiting

Last updated 2026-05-28

This clinical trial is testing a new implant that releases semaglutide under the skin to see if it is safe and well-tolerated in adults who are overweight or have obesity.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 20 people Planned (estimated).

Who can join Ages 18–60 · all sexes

Timeline Started 2026-04 · est. completion 2026-09

What this study is testing ClinicalTrials.gov NCT07430059 ↗

Description as written by the study sponsor.

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..

Treatments tested

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.

Main thing measured	Area under the plasma concentration-time curve (AUC)
Sponsor	Vivani Medical, Inc
Conditions studied	Obesity & Overweight
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07430059 ↗