NCT06608433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

September 19, 2024

Last Update Submit

February 10, 2026

Conditions

Healthy Volunteer StudyHPACortisol DeficiencyAdrenal Insufficiency

Keywords

Hypothalamo-pituitary-adrenal axisHealthy volunteersGlucagon-like peptide-1 receptor agonistsGLP-1 receptor agnoistssemaglutideadrenal insufficiencyHPA axisadrenal function testing

Outcome Measures

Primary Outcomes (1)

  • 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).

    within 210 minutes after the intake of the study drug

Study Arms (2)

Semaglutide/Rybelsus

EXPERIMENTAL
Drug: semaglutide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

semaglutideDRUG

semaglutide/Rybelsus will be administered as a single oral dose

Semaglutide/Rybelsus
PlaceboDRUG

Placebo pills will be administered as a single oral dose

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers aged 18-60 years
  • BMI 18.5-30 kg/m2
  • No regular medication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

January 16, 2025

Primary Completion

October 31, 2025

Study Completion

November 30, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)