Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:05 PM
Study NCT ID:
NCT06064006
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2023-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2025-11-17', 'completionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-28', 'dispFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PART A: Number of treatment emergent adverse events (TEAE)', 'timeFrame': 'From pre-dose on Day 1 until completion of the end of study visit, up to Day 25', 'description': 'Number of events'}, {'measure': 'PARTS B to E: Number of treatment emergent adverse events (TEAE)', 'timeFrame': 'From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270', 'description': 'Number of events'}], 'secondaryOutcomes': [{'measure': 'PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose', 'timeFrame': 'From pre-dose on Day 1 until completion of the end of study visit, up to Day 25', 'description': 'h\\*nmol/L'}, {'measure': 'PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax', 'timeFrame': 'From pre-dose on Day 1 until completion of the end of study visit, up to Day 25', 'description': 'nmol/L'}, {'measure': 'PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose', 'timeFrame': 'From pre-dose on V33D1 until end of treatment (V34) up to 9 days', 'description': 'h\\*nmol/L'}, {'measure': 'PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax', 'timeFrame': 'From pre-dose on V33D1 until end of study visit (V37) up to 24 days', 'description': 'nmol/L'}, {'measure': 'PART B to E: Relative change in body weight', 'timeFrame': 'From pre-dose on Day 1 until end of treatment (V34) up to Day 255', 'description': 'Percentage (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '40550231', 'type': 'DERIVED', 'citation': 'Dahl K, Toubro S, Dey S, Duque do Vale R, Flint A, Gasiorek A, Heydorn A, Jastreboff AM, Key C, Petersen SB, Vegge A, Adelborg K. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. 2025 Jul 12;406(10499):149-162. doi: 10.1016/S0140-6736(25)01185-7. Epub 2025 Jun 20.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female\n* Aged 18-55 years (both inclusive) at the time of signing informed consent.\n* Body Mass Index (BMI) between 27.0 and 39.9 kg/m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered eligible 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\nExclusion Criteria:\n\n* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol\n* HbA1c equal to or greater than 6.5 % (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 * Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening\n * Parathyroid hormone (PTH) outside normal range at screening\n * Total calcium outside normal range at screening\n * Amylase equal to or greater than 2 times upper limit of normal at screening\n * Lipase equal to or greater than 2 times upper limit of normal at screening\n * Calcitonin equal to or greater than 50 ng/L at screening"}, 'identificationModule': {'nctId': 'NCT06064006', 'briefTitle': 'A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'NN9490-7613'}, 'secondaryIdInfos': [{'id': 'U1111-1289-3282', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0487-0111', 'description': 'Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)', 'interventionNames': ['Drug: NNC0487-0111', 'Drug: Placebo (NNC0487-0111)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).', 'interventionNames': ['Drug: NNC0487-0111', 'Drug: Placebo (NNC0487-0111)']}], 'interventions': [{'name': 'NNC0487-0111', 'type': 'DRUG', 'description': 'NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.', 'armGroupLabels': ['NNC0487-0111', 'Placebo']}, {'name': 'Placebo (NNC0487-0111)', 'type': 'DRUG', 'description': 'Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.', 'armGroupLabels': ['NNC0487-0111', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase Services, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk INvestigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Transparency dept. 2834', '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'}}}}