Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

What Was Tested

This registered phase 1 trial tested Semaglutide.

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..

It had two arms (groups): Semaglutide Implant (NPM-139) (experimental) and Semaglutide (Wegovy) weekly injection (active comparator).

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.

The registry classes the interventions as combination product and drug.

More on the Plan

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.

Subsequently, participants will return to the clinic weekly until study end.

At each of these visits, participants will have blood samples drawn for PK.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI between 27 and 40 kg/m2 (inclusive).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: type 1 or type 2 diabetesa; treatment with glucose lowering agent(s) within 3 months before screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2026-07 with completion listed for 2026-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the plasma concentration-time curve (AUC) (time frame: 4 weeks). Maximum plasma concentration (Cmax) (time frame: 4 weeks). Time to maximum semaglutide concentration (Tmax) (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.