A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

This study investigates the Topical-Lingual (T-L) delivery of semaglutide, a GLP-1 receptor agonist (GLP-1RA), via an oral liquid emulsion formulation as a Proof-of-Concept for the T-L delivery of metabolic hormones in general.

GLP-1 is a gut-derived hormone that induces satiation through hypothalamic pathways.

It had three arms (groups): Semaglutide liquid emulsion formulation (experimental), Placebo liquid emulsion formulation (placebo comparator) and Wegovy Tablet (active comparator).

Placebo liquid emulsion formulation daily.

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Body Mass Index 30 to 45.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: type 2 diabetes mellitus; multiple endocrine neoplasia type 2; medullary thyroid cancer.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-06-17 with completion listed for 2027-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent body weight change from baseline (time frame: 24 weeks).

It also tracked 4 secondary outcomes, for example Change in hemoglobin A1c, Comparison of plasma semaglutide levels (Cmax) in 3 arms of study and Nausea Severity Scale.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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