A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

What Was Tested

This registered phase 1 trial tested Semaglutide.

This trial is conducted in Europe.

It had two arms (groups): Formulation A followed by Formulation B (experimental) and Formulation B followed by Formulation A (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 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: Body mass index (BMI) of 18.5-30 kg/m\^2 (both incl.).

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders; smoking, drug or alcohol abuse.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-12 with completion listed for 2013-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the plasma semaglutide concentration curve. Cmax, the maximum plasma semaglutide concentration.

It also tracked 5 secondary outcomes, for example The area under the plasma semaglutide concentration curve, tmax, time to Cmax of semaglutide, t½, terminal elimination half-life of semaglutide, Incidence of adverse events (AEs) and Hypoglycaemic episodes.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 28 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.