Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function

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.

Completed

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Key information

Conditions

Healthy Volunteer Study Adrenal Gland Diseases Adrenal Insufficiency Cortisol Deficiency Endocrine System Diseases HPA

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

semaglutide/Rybelsus will be administered as a single oral dose

Placebo

Drug

Placebo pills will be administered as a single oral dose

Primary outcomes

Change in serum cortisol after Rybelsus vs. Placebo

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study

Acronym: PIANO

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Sep 23, 2024
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed