Adrenal Insufficiency, Cortisol Deficiency, Healthy Volunteer Study, HPA
Conditions
Keywords
Hypothalamo-pituitary-adrenal axis, Healthy volunteers, Glucagon-like peptide-1 receptor agonists, GLP-1 receptor agnoists, semaglutide, adrenal insufficiency, HPA axis, adrenal function testing
Brief summary
This study aims to investigate the effects of a single dose of the glucagon-like 1 receptor agonist semaglutdie/Rybelsus on the hypothalamo-pituitary-adrenal axis, thus cortisol levels and other stresshormones in healthy males.
Interventions
DRUGsemaglutide
semaglutide/Rybelsus will be administered as a single oral dose
DRUGPlacebo
Placebo pills will be administered as a single oral dose
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers aged 18-60 years * BMI 18.5-30 kg/m2 * No regular medication
Exclusion criteria
* participation in a trial with investigational drugs within 30 days * vigorous physical exercise within 24 hours before the study participation * alcohol intake within 24 hours before the study participation * a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks. * Known allergy towards GLP-1 RA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum cortisol after Rybelsus vs. Placebo | within 210 minutes after the intake of the study drug | The primary endpoint is the difference between the two visits (placebo vs. Rybelsus) in the change in cortisol from cortisol baseline to the maximally stimulated cortisol value (cortisolmax). |
Countries
Switzerland
Outcome results
None listed