Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 2:49 AM
Study NCT ID:
NCT06577766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of treatment emergent adverse events (TEAE)', 'timeFrame': 'From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)', 'description': 'Measured as Number of events'}, {'measure': 'Part B,C,D : Number of treatment emergent adverse events (TEAE)', 'timeFrame': 'From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)', 'description': 'Measured as Number of events'}], 'secondaryOutcomes': [{'measure': 'Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve', 'timeFrame': 'From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)', 'description': 'Measured in hours\\*nano mole per litre (h\\*nmol/L)'}, {'measure': 'Part A: Cmax; maximum observed NNC0638-0355 plasma concentration', 'timeFrame': 'From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)', 'description': 'Measured in nano mole per litre (nmol/L)'}, {'measure': 'Part A: t½; terminal half-life of NNC0638-0355', 'timeFrame': 'From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)', 'description': 'Measured in hours (h)'}, {'measure': 'Part B,C,D: AUC; area under the NNC0638-0355 plasma concentration-time curve', 'timeFrame': 'From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)', 'description': 'Measured in hour\\*nano mole per litre (h\\*nmol/L)'}, {'measure': 'Part B,C,D: Cmax; maximum observed NNC0638-0355 plasma concentration', 'timeFrame': 'From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)', 'description': 'Measured in nano mole per litre (nmol/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key inclusion criteria\n\n* Male or female.\n* Age 18-55 years (both inclusive) at the time of signing the informed consent.\n* BMI between 25.0 and 34.9 kg/m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nKey exclusion criteria\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.\n* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:\n\n 1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening\n 2. Parathyroid hormone (PTH) outside normal range at screening\n 3. Total calcium outside normal range at screening"}, 'identificationModule': {'nctId': 'NCT06577766', 'briefTitle': 'A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'NN9638-7569'}, 'secondaryIdInfos': [{'id': 'U1111-1296-8015', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0638-0355', 'description': 'Participants will be randomized to receive NNC0638-0355. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD) Part B, C and D: Multiple ascending dose (MAD).', 'interventionNames': ['Drug: NNC0638-0355']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be randomized to receive Placebo. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD). Part B,C and D: Multiple ascending dose (MAD).', 'interventionNames': ['Drug: Placebo (NNC0638-0355)']}], 'interventions': [{'name': 'NNC0638-0355', 'type': 'DRUG', 'description': 'NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.', 'armGroupLabels': ['NNC0638-0355']}, {'name': 'Placebo (NNC0638-0355)', 'type': 'DRUG', 'description': 'Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://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'}}}}