Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-29 @ 9:38 AM
Study NCT ID:
NCT07087795
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)', 'timeFrame': 'From baseline (day -14 - -1) to day 36-49 / day 106-119', 'description': 'Percentage point (%-points).'}, {'measure': 'Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)', 'timeFrame': 'From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': '%-points.'}], 'secondaryOutcomes': [{'measure': 'Change in coefficient of variation (CV) of sensor glucose, total', 'timeFrame': 'Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': '%-points.'}, {'measure': 'Change in mean sensor glucose (SG)', 'timeFrame': 'Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': 'Millimoles per liter (mmol/L).'}, {'measure': 'Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)', 'timeFrame': 'Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': '%-points.'}, {'measure': 'Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)', 'timeFrame': 'Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': '%-points.'}, {'measure': 'Time below range (TBR) <3.9 mmol/L (70 mg/dL)', 'timeFrame': 'Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175', 'description': '% of time.'}, {'measure': 'Time below range (TBR)<3.0 mmol/L (54 mg/dL)', 'timeFrame': 'Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175', 'description': '% of time.'}, {'measure': 'Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)', 'timeFrame': 'Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175', 'description': '%-points.'}, {'measure': 'Change in mean total daily insulin dose per kg', 'timeFrame': 'Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175', 'description': 'Ratio to baseline.'}, {'measure': 'Change in triglycerides', 'timeFrame': 'Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176', 'description': 'Ratio to baseline.'}, {'measure': 'Number of adverse events (AEs)', 'timeFrame': 'Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211', 'description': 'Number of events.'}, {'measure': 'Number of severe hypoglycaemic episodes (level 3)', 'timeFrame': 'Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211', 'description': 'Number of episodes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female.\n* Age 18-64 years (both inclusive) at the time of signing the informed consent.\n* Body mass index 22-35 kilogram per square meter (kg/m\\^2) (both inclusive) for Part A and 27-35(kg/m\\^2) (both inclusive) for Part B at the day of screening.\n* Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.\n* Treated with multiple daily insulin injections and stable insulin dose greater than (\\>) 90 days prior to the day of screening, as judged by the investigator.\n* Use of Continuous glucose monitoring (CGM) device \\> 180 consecutive days prior to the day of screening.\n* Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).\n* Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) 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* Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.\n* Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.\n* Use of any medication with unknown or unspecified content within 90 days before screening.\n* Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).\n* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.\n* Any episode of diabetic ketoacidosis within 90 days before screening."}, 'identificationModule': {'nctId': 'NCT07087795', 'briefTitle': 'A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN6497-8316'}, 'secondaryIdInfos': [{'id': 'U1111-1315-5122', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2024-519533-38', 'type': 'OTHER', 'domain': 'European Medical Agency (EMA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: NNC0194-0499/Placebo', 'description': 'After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.', 'interventionNames': ['Drug: NNC0194-0499', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: NNC0194-0499/Placebo + Semaglutide', 'description': 'After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.', 'interventionNames': ['Drug: NNC0194-0499', 'Drug: Placebo', 'Drug: Semaglutide']}], 'interventions': [{'name': 'NNC0194-0499', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous NNC0194-0499 once weekly.', 'armGroupLabels': ['Part A: NNC0194-0499/Placebo', 'Part B: NNC0194-0499/Placebo + Semaglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo matched to NNC0194-0499 subcutaneously.', 'armGroupLabels': ['Part A: NNC0194-0499/Placebo', 'Part B: NNC0194-0499/Placebo + Semaglutide']}, {'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous semaglutide once weekly.', 'armGroupLabels': ['Part B: NNC0194-0499/Placebo + Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], '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'}}}}