protocolSection identificationModule nctId: NCT06326047, orgStudyIdInfo id: NN9541-4945, secondaryIdInfos id: U1111-1291-9196, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: jRCT2031230704, type: REGISTRY, domain: JRCT, briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-08-26, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 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 40 weeks., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: NNC0519-0130, interventions name: Placebo, interventions name: Trizepatide, outcomesModule primaryOutcomes measure: Change in Glycated haemoglobin (HbA1c), secondaryOutcomes measure: Change in Glycated haemoglobin (HbA1c), secondaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Change in fasting plasma glucose (FPG), secondaryOutcomes measure: Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)), secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure (SBP), secondaryOutcomes measure: Change in high sensitivity C-Reactive Protein (hsCRP), secondaryOutcomes measure: Change in total cholesterol, secondaryOutcomes measure: Change in high-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Change in low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Change in triglycerides, secondaryOutcomes measure: Number of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clin Res-Chula Vista, status: RECRUITING, city: Chula Vista, state: California, zip: 91911, country: United States, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Valley Research, status: NOT_YET_RECRUITING, city: Fresno, state: California, zip: 93720, country: United States, geoPoint lat: 36.74773, lon: -119.77237, locations facility: Valley Research, status: WITHDRAWN, city: Fresno, state: California, zip: 93720, country: United States, geoPoint lat: 36.74773, lon: -119.77237, locations facility: Velocity Clin Res San Diego, status: RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, geoPoint lat: 32.76783, lon: -117.02308, locations facility: First Valley Med Grp Lancaster, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: Torrance Clin Res Inst, Inc., status: RECRUITING, city: Lomita, state: California, zip: 90717, country: United States, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Pacific Clinical Studies, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Catalina Research Institute, LLC, status: RECRUITING, city: Montclair, state: California, zip: 91763, country: United States, geoPoint lat: 34.07751, lon: -117.68978, locations facility: Med Partners, Inc., status: RECRUITING, city: Toluca Lake, state: California, zip: 91602, country: United States, geoPoint lat: 34.15262, lon: -118.35731, locations facility: UCLA Health Southbay Endocrine, status: NOT_YET_RECRUITING, city: Torrance, state: California, zip: 90505, country: United States, geoPoint lat: 33.83585, lon: -118.34063, locations facility: University Clin Investigators, status: RECRUITING, city: Tustin, state: California, zip: 92780, country: United States, geoPoint lat: 33.74585, lon: -117.82617, locations facility: University of Colorado Hospital, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Innovative Research of W Florida Inc., status: RECRUITING, city: Clearwater, state: Florida, zip: 33756, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: International Research Associates, LLC_Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33183, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Centricity Research, status: RECRUITING, city: Columbus, state: Georgia, zip: 31904, country: United States, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Elite Clinical Trials, status: RECRUITING, city: Blackfoot, state: Idaho, zip: 83221, country: United States, geoPoint lat: 43.19047, lon: -112.34498, locations facility: Methodist Medical_Center of Illinois, status: RECRUITING, city: Peoria, state: Illinois, zip: 61636, country: United States, geoPoint lat: 40.69365, lon: -89.58899, locations facility: MD Medical Research, status: RECRUITING, city: Oxon Hill, state: Maryland, zip: 20745, country: United States, geoPoint lat: 38.80345, lon: -76.9897, locations facility: Endo And Metab Cons, status: WITHDRAWN, city: Rockville, state: Maryland, zip: 20852, country: United States, geoPoint lat: 39.084, lon: -77.15276, locations facility: Clinvest Research, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Mercury Str Med Grp, PLLC, status: RECRUITING, city: Butte, state: Montana, zip: 59701, country: United States, geoPoint lat: 46.00382, lon: -112.53474, locations facility: Palm Research Center Inc-Vegas, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Velocity Clinical Research Binghamton, status: RECRUITING, city: Binghamton, state: New York, zip: 13905, country: United States, geoPoint lat: 42.09869, lon: -75.91797, locations facility: PharmQuest Life Sciences LLC, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Accellacare Wilmington, status: NOT_YET_RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Accellacare Wilmington, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Diab & Endo Assoc of Stark Co, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Velocity Clin Res_Cincinnati, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Velocity Clinical Research Springdale, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45246, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Providence Health Partners Ctr, status: RECRUITING, city: Dayton, state: Ohio, zip: 45439, country: United States, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Advanced Med Res Maumee, status: RECRUITING, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: Tristar Clin Investigations, PC, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19114, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians Inc., status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Preferred Primary Care Physicians, Inc., status: RECRUITING, city: Uniontown, state: Pennsylvania, zip: 15401, country: United States, geoPoint lat: 39.90008, lon: -79.71643, locations facility: Velocity Clinical Research Abilene, status: RECRUITING, city: Abilene, state: Texas, zip: 79606, country: United States, geoPoint lat: 32.44874, lon: -99.73314, locations facility: Velocity Clin Res Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Endocrine Associates Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Biopharma Informatic_Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77043, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Biopharma Informatic_Houston, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77043, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Burke Internal Medicine & Research, status: RECRUITING, city: Burke, state: Virginia, zip: 22015, country: United States, geoPoint lat: 38.79345, lon: -77.27165, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Macquarie University, status: NOT_YET_RECRUITING, city: Macquarie Park, state: New South Wales, zip: 2109, country: Australia, geoPoint lat: -33.7751, lon: 151.11272, locations facility: Royal North Shore Hospital, status: NOT_YET_RECRUITING, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, geoPoint lat: -33.82344, lon: 151.19836, locations facility: Western Endocrine Blacktown, status: NOT_YET_RECRUITING, city: Sydney, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Western Endocrine Blacktown, status: WITHDRAWN, city: Sydney, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Illawarra Diabetes Service Clinical Trials & Research Unit, status: NOT_YET_RECRUITING, city: Wollongong, state: New South Wales, zip: 2500, country: Australia, geoPoint lat: -34.424, lon: 150.89345, locations facility: University of Sunshine Coast, status: NOT_YET_RECRUITING, city: Birtinya, state: Queensland, zip: 4575, country: Australia, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Eastern Clinical Research Unit Box Hill, status: NOT_YET_RECRUITING, city: Box Hill, state: Victoria, zip: 3128, country: Australia, geoPoint lat: -37.81887, lon: 145.12545, locations facility: Austin Health, Metabolic Disorders Centre, status: NOT_YET_RECRUITING, city: Heidelberg Heights, state: Victoria, zip: 3081, country: Australia, geoPoint lat: -37.74313, lon: 145.05695, locations facility: The Royal Melbourne Hospital, status: NOT_YET_RECRUITING, city: Parkville, state: Victoria, zip: 3050, country: Australia, geoPoint lat: -37.78333, lon: 144.95, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), status: RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), status: NOT_YET_RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Cook Street Medical Clinic, status: RECRUITING, city: Victoria, state: British Columbia, zip: V8V 4A1, country: Canada, geoPoint lat: 48.43294, lon: -123.3693, locations facility: G.A. Research Associates Ltd., status: RECRUITING, city: Moncton, state: New Brunswick, zip: E1G 1A7, country: Canada, geoPoint lat: 46.09454, lon: -64.7965, locations facility: Nova Scotia Hlth Halifax, status: NOT_YET_RECRUITING, city: Halifax, state: Nova Scotia, zip: B3H 1V7, country: Canada, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Wharton Med Clin Trials, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Albion Finch Medical Centre, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M9V 4B4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Albion Finch Medical Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M9V 4B4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centricity Research Quebec City, status: RECRUITING, city: Levis, state: Quebec, zip: G6W 0M5, country: Canada, geoPoint lat: 46.80326, lon: -71.17793, locations facility: Recherche GCP Research, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H1Y 3H5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centricity Research Ville St. Laurent VSL, status: WITHDRAWN, city: Ville Saint-Laurent, state: Quebec, zip: H4T 1Z9, country: Canada, locations facility: Diex Recherche Quebec Inc., status: NOT_YET_RECRUITING, city: Quebec, zip: G1V 4T3, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Life Care Clinic & Research Centre, status: NOT_YET_RECRUITING, city: Bangalore, state: Karnataka, zip: 560092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Amrita Institute Of Medical Sciences & Research Centre, status: NOT_YET_RECRUITING, city: Kochi, state: Kerala, zip: 682041, country: India, geoPoint lat: 9.93988, lon: 76.26022, locations facility: Seth GS Medical College & KEM Hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Chellaram Diabetes Institute, status: NOT_YET_RECRUITING, city: Pune, state: Maharashtra, zip: 411021, country: India, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Christian Medical College Hospital, Vellore, status: NOT_YET_RECRUITING, city: Vellore, state: Tamil Nadu, zip: 632004, country: India, geoPoint lat: 12.9184, lon: 79.13255, locations facility: Kumudini Devi Diabetes Research Center, Ramdevrao Hospital, status: NOT_YET_RECRUITING, city: Hyderabad, state: Telangana, zip: 500072, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: MS Ramaiah, status: NOT_YET_RECRUITING, city: Bengaluru, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Tokuyama clinic, status: RECRUITING, city: Chiba, zip: 261-0004, country: Japan, geoPoint lat: 35.6, lon: 140.11667, locations facility: Soka Sugiura 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country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Anam Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kangbuk Samsung Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 03181, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, status: NOT_YET_RECRUITING, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Josha Research, status: WITHDRAWN, city: Bloemfontein, state: Free State, zip: 9301, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Wits Bara Clinical Trial Site, status: WITHDRAWN, city: Johannesburg, state: Gauteng, zip: 2013, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Shop#1 Health Emporium, status: WITHDRAWN, city: Midrand, state: 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