Healthy Volunteer StudyPIANONCT06608433
Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function
A study testing semaglutide in people with Healthy Volunteer Study and HPA, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study, HPA, Cortisol Deficiency
- What is being tested?
- semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18-60 years
- BMI 18.5-30 kg/m2
- No regular medication
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study
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.
- Being tested
- semaglutide, Placebo
- 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
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
semaglutide/Rybelsus will be administered as a single oral dose
PlaceboDrug
Placebo pills will be administered as a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide/Rybelsus | Experimental | Not described Receives: Drug: semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 210 minutes after the intake of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start16 Jan 2025
- Primary completion31 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608433
- Sponsor's protocol ID
- EKNZ2024-01744
- Acronym
- PIANO
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study
- ClinicalTrials.gov ID
- NCT06608433
- Acronym / sponsor ID
- PIANO / EKNZ2024-01744
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide/Rybelsus | Experimental | Drug: semaglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged 18-60 years
- BMI 18.5-30 kg/m2
- No regular medication
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutidesemaglutide/Rybelsus will be administered as a single oral dose | Drug | Semaglutide/Rybelsus |
| PlaceboPlacebo pills will be administered as a single oral dose | Drug | Placebo |
Primary outcome
Change in serum cortisol after Rybelsus vs. Placebo
Time frame: within 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semaglutide in people with Healthy Volunteer Study and HPA, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum cortisol after Rybelsus vs. Placebo (time frame: within 210 minutes after the intake of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.