Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 7:56 AM
Study NCT ID:
NCT05254158
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in h·nmol/L'}], 'secondaryOutcomes': [{'measure': 'AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose', 'timeFrame': 'From pre-dose (Day 1) to Visit 3 (Day 8)', 'description': 'measured in h·nmol/L'}, {'measure': 'Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in nmol/L'}, {'measure': 'tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in hours'}, {'measure': 't1/2, NNC0174-0833: The terminal half-life of NNC0174-0833', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in hours'}, {'measure': 'CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in L/h'}, {'measure': 'Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in L'}, {'measure': 'Change in body weight', 'timeFrame': 'From pre-dose (Day 1) to Visit 7 (Day 36)', 'description': 'measured in percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.\n\nThe study compares three different doses of the study medicine in Chinese healthy men.\n\nParticipant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.\n\nNNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.\n\nWe are testing the study medicine to make a medicine that can help people lose weight.\n\nParticipant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.\n\nThe study will last for about 5 months. But participants participation will last about 2 months.\n\nParticipant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.\n\nAt all visits, except the information visit, participant will have blood drawn along with other clinical examinations.\n\nParticipants will be asked about their health, medical history and habits including mental health.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key inclusion criteria\n\n* Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.\n* Body mass index (BMI) between 20.0 and 39.9 kg/m\\^2 (both inclusive) at screening.\n* Body weight between 60.0 and 110.0 kg (both inclusive) at screening.\n\nKey exclusion criteria\n\n* Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').\n* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT05254158', 'briefTitle': 'A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity', 'orgStudyIdInfo': {'id': 'NN9838-4615'}, 'secondaryIdInfos': [{'id': 'U1111-1247-7538', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0174 0833 1.8 mg', 'description': 'Each participant will receive one single dose of NNC0174 0833', 'interventionNames': ['Drug: NNC0174 0833']}, {'type': 'EXPERIMENTAL', 'label': 'NNC0174 0833 0.9 mg', 'description': 'Each participant will receive one single dose of NNC0174 0833', 'interventionNames': ['Drug: NNC0174 0833']}, {'type': 'EXPERIMENTAL', 'label': 'NNC0174 0833 0.3 mg', 'description': 'Each participant will receive one single dose of NNC0174 0833', 'interventionNames': ['Drug: NNC0174 0833']}], 'interventions': [{'name': 'NNC0174 0833', 'type': 'DRUG', 'description': 'Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)', 'armGroupLabels': ['NNC0174 0833 0.3 mg', 'NNC0174 0833 0.9 mg', 'NNC0174 0833 1.8 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': '"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}