Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

What Was Tested

In this not phased trial, researchers set out to test Macimorelin (non-peptide).

This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy.

An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: No medication except hormonal contraception.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: body mass index (bmi) \> 40kg/m2 or bmi \< 18.5 kg/m2; participation in a trial with investigational drugs within 30 days; vigorous physical exercise within 24 hours before the study participation.

How the Study Was Run

The set-up was sequential and open-label.

Everyone knew when Macimorelin (non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-03-07 with completion listed for 2019-07-16.

It ran at 1 site in Switzerland.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Change in Copeptin value (pmol/l), after intake of Macimorelin of [amount hidden] body weight.

It also tracked 10 secondary outcomes, for example Change in Growth Hormone (GH) value (ng/mL), Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL), Change in free thyroxine (fT4) value (ng/dL), Change in Thyreotropin (TSH) value (mU/L), Change in Prolactin value (yg/L) and Change in Cortisol value (ng/mL).

What This Means in Plain Language

Put simply, this is a not phased trial of Macimorelin (non-peptide) in 28 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 Macimorelin (non-peptide) compound page, all human trials.