Glucagon-like Peptide-1 Receptor Agnoists for the Assessm... | NCT06608433

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

NCT06608433

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Feb 11, 2026Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Healthy Volunteer Study
HPA
Cortisol Deficiency
Adrenal Insufficiency

Interventions

semaglutide
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2025Actual

Primary Completion Date

Oct 31, 2025Actual

Completion Date

Nov 30, 2025Actual

First Submitted Date

Sep 19, 2024

First Submission Date that Met QC Criteria

Sep 19, 2024

First Posted Date

Sep 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

Conditions

Healthy Volunteer Study
HPA
Cortisol Deficiency
Adrenal Insufficiency

Keywords

Hypothalamo-pituitary-adrenal axis
Healthy volunteers
Glucagon-like peptide-1 receptor agonists
GLP-1 receptor agnoists
semaglutide
adrenal insufficiency
HPA axis
adrenal function testing

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide/Rybelsus	Experimental		Drug: semaglutide
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	semaglutide/Rybelsus will be administered as a single oral dose	Semaglutide/Rybelsus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000309	Adrenal Insufficiency

Ancestor Terms

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000591245	semaglutide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided