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

Not Applicable
Recruiting
Conditions
HPA
Adrenal Insufficiency
Healthy Volunteer Study
Cortisol Deficiency
Interventions
Drug: Placebo
Registration Number
NCT06608433
Lead Sponsor
University Hospital, Basel, Switzerland
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
Semaglutide/Rybelsussemaglutide-
Primary Outcome Measures
NameTimeMethod
Change in serum cortisol after Rybelsus vs. Placebowithin 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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital Basel

🇨🇭

Basel, Switzerland

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