A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

What Was Tested

This registered phase 1 trial tested Semaglutide.

This trial is conducted in Europe.

It had three arms (groups): A (experimental), B (experimental) and C (experimental).

The registry classes the interventions as drug.

Who Took Part

44 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator. Body weight between 80 kg and 110 kg (both inclusive). Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; previous participation in this trial (randomisation); the receipt of any investigational medicinal product within 3 months prior to this trial.

How the Study Was Run

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

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

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2009-01 with completion listed for 2009-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration (time frame: a 28 day time period).

It also tracked 1 secondary outcome, for example Cmax of the plasma NN9535 curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 44 people.

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.