Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02557620
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-02', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the semaglutide concentration-time curves', 'timeFrame': 'At steady-state from 0 to168 hours after dosing on day 78'}], 'secondaryOutcomes': [{'measure': 'Maximum observed semaglutide plasma concentration', 'timeFrame': 'At steady-state derived from the concentration-time curves, within 168 hours from day 78'}, {'measure': 'Number of treatment emergent adverse events (TEAEs)', 'timeFrame': 'From baseline (day 1, post-dose) to last follow-up visit (day 120)'}, {'measure': 'Area under the the single dose concentration-time curve', 'timeFrame': 'From 0 to 300 min after administration of paracetamol (1.5 g) at day 51'}, {'measure': 'Area under the the single dose concentration-time curve', 'timeFrame': 'From 0 to 300 min after administration of paracetamol (1.5 g) at day 79'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator\n* Body mass index (BMI) between 20.0 and 29.9 kg/m\\^2 (both inclusive)\n* HbA1c (glycosylated haemoglobin) below 6.5%\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)\n* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol\n* History of pancreatitis (acute or chronic)\n* Screening calcitonin equal or above 50 ng/L\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)"}, 'identificationModule': {'nctId': 'NCT02557620', 'briefTitle': 'Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly', 'orgStudyIdInfo': {'id': 'NN9535-4215'}, 'secondaryIdInfos': [{'id': '2014-005171-84', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1164-2741', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'semaglutide OD + placebo semaglutide OW', 'interventionNames': ['Drug: semaglutide', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo semaglutide OW + placebo semaglutide OD', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'semaglutide OW + placebo semaglutide OD', 'interventionNames': ['Drug: semaglutide', 'Drug: placebo']}], 'interventions': [{'name': 'semaglutide', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin)once daily or once weekly.', 'armGroupLabels': ['semaglutide OD + placebo semaglutide OW', 'semaglutide OW + placebo semaglutide OD']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin)once daily or once weekly.', 'armGroupLabels': ['placebo semaglutide OW + placebo semaglutide OD', 'semaglutide OD + placebo semaglutide OW', 'semaglutide OW + placebo semaglutide OD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}