Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Europe.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 170 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Body Mass Index (BMI) between 20 and 30 kg/m\^2.

The full record lists 3 inclusion and 2 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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 and investigator.

It started in 2013-05 with completion listed for 2014-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Part A: Number of treatment emergent adverse events (TEAEs) (time frame: Day -1 to Day 24). Part B: Number of treatment emergent adverse events (TEAEs).

It also tracked 4 secondary outcomes, for example Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve, Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve, Part B: Change in fasting plasma glucose (FPG) from baseline and Part B: Change in body weight from baseline.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 170 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.