A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

What Was Tested

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

Both drug concentrations are tested for the treatment of type 2 diabetes.

Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form.

It had two arms (groups): Sequence A (experimental) and Sequence B (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female. Aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; abuse or intake of alcohol, defined as any of the below:; positive alcohol test at screening.

How the Study Was Run

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

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.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

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

It started in 2023-01-17 with completion listed for 2023-05-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

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.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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