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

University Hospital, Basel, Switzerland22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer Study HPA Cortisol Deficiency Adrenal Insufficiency

Interventions

semaglutideDRUG

semaglutide/Rybelsus will be administered as a single oral dose

PlaceboDRUG

Placebo pills will be administered as a single oral dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in serum cortisol after Rybelsus vs. Placebo

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).

Time frame: within 210 minutes after the intake of the study drug

Data from ClinicalTrials.gov

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