Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

What Was Tested

This registered phase 1 trial tested Semaglutide.

This trial is conducted in Europe.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 7 actual participants took part.

It was open to men only aged from 45 years up to 64 years.

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

Examples of who could join: Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator. Age between 45-64 years (both inclusive) at the time of signing inform consent. Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test; smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-02-04 with completion listed for 2014-04-28.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces.

It also tracked 5 secondary outcomes, for example Blood to plasma ratio of [3H]-semaglutide related material, Area under the semaglutide plasma concentration curve and Maximum observed semaglutide plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 7 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.