Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-29 @ 12:52 AM
Study NCT ID:
NCT06608433
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum cortisol after Rybelsus vs. Placebo', 'timeFrame': 'within 210 minutes after the intake of the study drug', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Healthy Volunteer Study', 'HPA', 'Cortisol Deficiency', 'Adrenal Insufficiency']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers aged 18-60 years\n* BMI 18.5-30 kg/m2\n* No regular medication\n\nExclusion Criteria:\n\n* participation in a trial with investigational drugs within 30 days\n* vigorous physical exercise within 24 hours before the study participation\n* alcohol intake within 24 hours before the study participation\n* a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks.\n* Known allergy towards GLP-1 RA'}, 'identificationModule': {'nctId': 'NCT06608433', 'acronym': 'PIANO', 'briefTitle': 'Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study', 'orgStudyIdInfo': {'id': 'EKNZ2024-01744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide/Rybelsus', 'interventionNames': ['Drug: semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'semaglutide', 'type': 'DRUG', 'description': 'semaglutide/Rybelsus will be administered as a single oral dose', 'armGroupLabels': ['Semaglutide/Rybelsus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo pills will be administered as a single oral dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sandrine Urwyler, PD Dr', 'role': 'CONTACT', 'email': 'sandrine.urwyler@usb.ch', 'phone': '004 61 265 50 78'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Sandrine Urwyler, PD Dr. med.', 'role': 'CONTACT', 'email': 'sandrine.urwyler@usb.ch', 'phone': '+41 61 265 50 78'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}