The Effect of Semaglutide on Pituitary Function

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had three arms (groups): one (active comparator), Placebo (placebo comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study group and order of administration of study medication are decided on randomization.

The placebo and oral semaglutide are administered at least 4 weeks apart.

Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).

The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Age 18-50 years. The body weight \>65 kg.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: presence of chronic illness; the daily use of medications.

How the Study Was Run

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

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

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

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 care provider.

It started in 2021-05-19 with completion listed for 2021-09-23.

It ran at 1 site in Estonia.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Growth hormone peak (time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration).

It also tracked 6 secondary outcomes, for example Cortisol peak, Adrenocorticotropin (ACTH) peak, Aldosterone peak, Glucose nadir, C-peptide peak and Copeptin peak.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 10 people.

Its size is small, so on its own it can only give an early look.

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.