A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

It had four arms (groups): Cohort A0 : Semaglutide Nasal Spray (experimental), Cohort A1: Semaglutide nasal spray and placebo (experimental), Cohort A2:Semaglutide nasal spray and placebo (experimental) and Cohort A3: Semaglutide injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 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: Male or female participants aged ≥18 years and ≤ 65 years. Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive). Negative anti-HIV antibody test result at screening.

The full record lists 6 inclusion and 45 exclusion criteria; among the exclusions: diagnosis of type 1, type 2, or other forms of diabetes mellitus; use of any of the following treatments within 3 months prior to screening:; any antidiabetic medications (e.g., odium-glucose cotransporter-2 inhibitors (sglt2) inhibitors, metformin, alpha-glucosidase inhibitors, insulin);.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2026-03-02 with completion listed for 2026-08-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum Plasma Concentration (Cmax) (time frame: Day 1 to Day 36 after administration). Time to maximum concentration(Tmax) (time frame: Day 1 to Day 36 after administration). Area under the concentration-time curve from time 0 to time t (AUC0-t) (time frame: Day 1 to Day 36 after administration).

It also tracked 4 secondary outcomes, for example Positive rate of Anti-Drug Antibody (ADA), Titer of Anti-Drug Antibody (ADA), Positive rate of Neutralizing antibody (Nab) and Titer of Neutralizing antibody (Nab).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 60 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.