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

University Hospital Basel

Status: Enrolling

Conditions: Cortisol Deficiency; HPA; Adrenal Insufficiency; Healthy Volunteer Study

Treatments: Drug: semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06608433

EKNZ2024-01744

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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23 participants in 2 patient groups, including a placebo group

Semaglutide/Rybelsus

Experimental group

Treatment:

Drug: semaglutide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo