A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Asia.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 48 actual participants took part.

It was open to men only aged from 20 years up to 55 years.

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

Examples of who could join: Healthy male Japanese and Caucasian subjects. Age between 20 and 55 years (both inclusive) at time of signing informed consent. Body weight of above or equal to 54.0 kg. Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2); history of chronic pancreatitis or idiopathic acute pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

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 2014-06 with completion listed for 2014-11.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the semaglutide plasma concentration-time curve.

It also tracked 2 secondary outcomes, for example Maximum observed semaglutide plasma concentration and Number of treatment emergent adverse events (TEAEs) recorded.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 48 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.