Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT06326060
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, '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': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-03-16', 'studyFirstSubmitQcDate': '2024-03-16', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative change in body weight', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in percentage of body weight.'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in kilograms (kg)'}, {'measure': 'Achievement of greater than equal to (≥) 5% weight reduction', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Count of participants'}, {'measure': 'Achievement of ≥ 10% weight reduction', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Count of participants'}, {'measure': 'Achievement of ≥ 15% weight reduction', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Count of participants'}, {'measure': 'Achievement of ≥ 20% weight reduction', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Count of participants'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in Kilogram per meter square (Kg/m\\^2)'}, {'measure': 'Change in waist circumference', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in centimeter (cm)'}, {'measure': 'Change in glycated hemoglobin (HbA1c)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in percentage point (%-point)'}, {'measure': 'Change in fasting plasma glucose (FPG)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in millimoles per liter (mmol/L)'}, {'measure': 'Change in systolic blood pressure (SBP)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Measured in milliters of mercury (mmHg)'}, {'measure': 'Change in high sensitivity C-Reactive protein (hsCRP)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Ratio to baseline'}, {'measure': 'Change in total cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Ratio to baseline'}, {'measure': 'Change in high-density lipoprotein (HDL) cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Ratio to baseline'}, {'measure': 'Change in low-density lipoprotein (LDL) cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Ratio to baseline'}, {'measure': 'Change in triglycerides', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'Ratio to baseline'}, {'measure': 'Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).'}, {'measure': 'Change in IWQOL-Lite-CT Psychosocial composite score', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).'}, {'measure': 'Change in IWQOL-Lite-CT Physical Function score', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).'}, {'measure': 'Change in IWQOL-Lite-CT Total score', 'timeFrame': 'From baseline (week 0) to end of treatment (week 36)', 'description': 'IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).'}, {'measure': 'Number of adverse events', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Count of events'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female of non-childbearing potential, or male.\n\n a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.\n* Age 18-75 years (both inclusive) at the time of signing the informed consent.\n* History of at least one self-reported unsuccessful dietary effort to lose body weight.\n* a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.\n* b) BMI ≥ 30.0 kg/m2.\n\nExclusion Criteria:\n\n* HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus.\n* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.'}, 'identificationModule': {'nctId': 'NCT06326060', 'briefTitle': 'A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study', 'orgStudyIdInfo': {'id': 'NN9541-5015'}, 'secondaryIdInfos': [{'id': 'U1111-1291-9210', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': 'jRCT2051230198', 'type': 'REGISTRY', 'domain': 'JRCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing scheme a: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme a: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing scheme b: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme b: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing scheme c: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme c: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing scheme d: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme d: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing scheme e: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme e: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing scheme f: NNC0519-0130', 'description': 'Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: NNC0519-0130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing scheme f: Placebo', 'description': 'Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dosing scheme g: Tirzepatide', 'description': 'Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.', 'interventionNames': ['Drug: Tirzepatide']}], 'interventions': [{'name': 'NNC0519-0130', 'type': 'DRUG', 'description': 'NNC0519-0130 will be administered subcutaneously.', 'armGroupLabels': ['Dosing scheme a: NNC0519-0130', 'Dosing scheme b: NNC0519-0130', 'Dosing scheme c: NNC0519-0130', 'Dosing scheme d: NNC0519-0130', 'Dosing scheme e: NNC0519-0130', 'Dosing scheme f: NNC0519-0130']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered subcutaneously.', 'armGroupLabels': ['Dosing scheme a: Placebo', 'Dosing scheme b: Placebo', 'Dosing scheme c: Placebo', 'Dosing scheme d: Placebo', 'Dosing scheme e: Placebo', 'Dosing scheme f: Placebo']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Tirzepatide will be administered subcutaneously.', 'armGroupLabels': ['Dosing scheme g: Tirzepatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Centricity Research-Arizona', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Unity Health-Searcy Medical Center', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'zip': '92627', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'FDRC', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado at Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34429', 'city': 'Crystal River', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.90248, 'lon': -82.5926}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Research Institute', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Ctr For Clin Res', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60607', 'city': 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