Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

This trial is conducted in Europe.

It had ten arms (groups): A (experimental), B (experimental), C (experimental), D (experimental) and E (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

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

Examples of who could join: For Caucasian or Japanese volunteers the following applies:. Informed consent obtained before any trial-related activities. Body weight between 54 and 90 kg (both inclusive). Body mass index (BMI) between 18.5 and 24.9 kg/m2 (both inclusive). Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator.

The full record lists 8 inclusion and 21 exclusion criteria; among the exclusions: previous randomised in this trial (not applicable for stand-by volunteers); heart rate in supine position at the screening, after resting for 5 min, consistently above 100 beats/min; alcohol intake within 48 hours prior to the screening and admission (examined by alcohol breath test).

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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-02 with completion listed for 2009-10.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Adverse events (time frame: at all scheduled visits (2 - 14) following screening).

It also tracked 8 secondary outcomes, for example Frequency of hypoglycaemic episodes, Vital signs (blood pressure and pulse), 12-lead ECG (electrocardiogram), Haematology, Biochemistry and Urinalysis.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 84 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.