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

NCT ID: NCT06608433

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-16

Study Completion Date

2025-08-31

Brief Summary

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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

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Conditions

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Healthy Volunteer Study HPA Cortisol Deficiency Adrenal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Semaglutide/Rybelsus

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

semaglutide/Rybelsus will be administered as a single oral dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pills will be administered as a single oral dose

Interventions

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semaglutide

semaglutide/Rybelsus will be administered as a single oral dose

Intervention Type DRUG

Placebo

Placebo pills will be administered as a single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Sandrine Urwyler, PD Dr. med.

Role: CONTACT

+41 61 265 50 78

Facility Contacts

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Sandrine Urwyler, PD Dr

Role: primary

004 61 265 50 78

Other Identifiers

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EKNZ2024-01744

Identifier Type: -

Identifier Source: org_study_id

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