Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics 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): NNC 0113-0217 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

58 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Subject is male. Age 18-65 years, both included. Body Mass Index (BMI) below 35.0 kg/m\^2 (Body weight between 50 kg -150 kg, both inclusive). Good general health based on medical history, physical examination including ECG (Electrocardiogram) and laboratory analysis, as judged by the investigator.

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: patients with mi (myocardia-infarction) during the last 12 month; use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine); current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers, and mao (mono-amino-oxidase) inhibitors.

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.

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 2007-06-11 with completion listed for 2007-10-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Adverse Events (time frame: After 24-33 days).

It also tracked 5 secondary outcomes, for example Area under the curve of NNC 0113-0217, Area under the curve of NNC 0113-0217, Morning fasting plasma glucose, Morning fasting insulin and Morning fasting glucagon.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 58 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.