A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of 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 four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 44 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 the time of signing informed consent. Body weight of equal to or above 54.0 kg. Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive). For Japanese subjects only: both parents Japanese.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men2); history of chronic pancreatitis or idiopathic acute pancreatitis; calcitonin above or equal to 50 ng/l.

How the Study Was Run

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

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 2014-05-21 with completion listed for 2014-10-20.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the plasma semaglutide concentration-time curve.

It also tracked 3 secondary outcomes, for example Maximum observed plasma semaglutide concentration at steady state, Change in body weight from baseline to the end of treatment and Number of treatment emergent adverse events (TEAEs) from baseline to follow-up.

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.