protocolSection identificationModule nctId: NCT06326060, orgStudyIdInfo id: NN9541-5015, secondaryIdInfos id: U1111-1291-9210, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: jRCT2051230198, type: REGISTRY, domain: JRCT, briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-05-05, 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 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., conditionsModule conditions: Obesity, 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 343, type: ESTIMATED, armsInterventionsModule interventions name: NNC0519-0130, interventions name: Placebo, interventions name: Tirzepatide, outcomesModule primaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Achievement of greater than equal to (≥) 5% weight reduction, secondaryOutcomes measure: Achievement of ≥ 10% weight reduction, secondaryOutcomes measure: Achievement of ≥ 15% weight reduction, secondaryOutcomes measure: Achievement of ≥ 20% weight reduction, secondaryOutcomes measure: Change in body mass index (BMI), secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in glycated hemoglobin (HbA1c), secondaryOutcomes measure: Change in fasting plasma glucose (FPG), 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: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Psychosocial composite score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Physical Function score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Total score, secondaryOutcomes measure: Number of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centricity Research-Arizona, status: WITHDRAWN, city: Mesa, state: Arizona, zip: 85206, country: United States, geoPoint lat: 33.42227, lon: -111.82264, locations facility: Arkansas Clinical Research, status: WITHDRAWN, city: Little Rock, state: Arkansas, zip: 72205, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Unity Health-Searcy Medical Center, status: RECRUITING, city: Searcy, state: Arkansas, zip: 72143, country: United States, geoPoint lat: 35.25064, lon: -91.73625, locations facility: FDRC, status: RECRUITING, city: Costa Mesa, state: California, zip: 92627, country: United States, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Diablo Clinical Research, Inc., status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Univ of Colorado at Denver, status: WITHDRAWN, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Nature Coast Clinical Research, status: RECRUITING, city: Crystal River, state: Florida, zip: 34429, country: United States, geoPoint lat: 28.90248, lon: -82.5926, locations facility: Northeast Research Institute, status: RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Jacksonville Ctr For Clin Res, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Cedar-Crosse Research Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60607, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Midwest Inst For Clin Res, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Velocity Clin. Res Valparaiso, status: RECRUITING, city: Valparaiso, state: Indiana, zip: 46383, country: United States, geoPoint lat: 41.47309, lon: -87.06114, locations facility: L-MARC Research Center, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40213, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Centennial Medical Group, status: RECRUITING, city: Columbia, state: Maryland, zip: 21045, country: United States, geoPoint lat: 39.24038, lon: -76.83942, locations facility: StudyMetrix Research LLC, status: RECRUITING, city: Saint Peters, state: Missouri, zip: 63303, country: United States, geoPoint lat: 38.80033, lon: -90.62651, locations facility: NYU Bariatric Surgical Ctr, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Medication Mgmnt, LLC_Grnsboro, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27405, country: United States, geoPoint lat: 36.07264, lon: -79.79198, 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: Physicians East Endocrinology, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Piedmont Healthcare, status: RECRUITING, city: Statesville, state: North Carolina, zip: 28625, country: United States, geoPoint lat: 35.78264, lon: -80.8873, 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: Remington Davis Inc, status: RECRUITING, city: Columbus, state: Ohio, zip: 43215, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Family Practice Center of Wadsworth Inc., status: RECRUITING, city: Wadsworth, state: Ohio, zip: 44281-9236, country: United States, geoPoint lat: 41.02561, lon: -81.72985, locations facility: Lynn Institute of Norman, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73072, country: United States, geoPoint lat: 35.22257, lon: -97.43948, locations facility: The University of Penn Center, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104-3317, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians_Pittsburgh, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Velocity Clin Res Providence, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Medical University Of South Carolina, status: NOT_YET_RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Spartanburg Medical Research, status: RECRUITING, city: Spartanburg, state: South Carolina, zip: 29303, country: United States, geoPoint lat: 34.94957, lon: -81.93205, locations facility: Holston Medical Group Pc, status: RECRUITING, city: Bristol, state: Tennessee, zip: 37620-7352, country: United States, geoPoint lat: 36.59511, lon: -82.18874, locations facility: Baylr Sctt White Rs Inst, Endo, status: WITHDRAWN, city: Dallas, state: Texas, zip: 75226, country: United States, geoPoint lat: 32.78306, lon: -96.80667, 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: North Texas Endocrine Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: UT Southwestern Medical Center - Lingvay, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: DCOL Ctr for Clin Res, status: RECRUITING, city: Longview, state: Texas, zip: 75605, country: United States, geoPoint lat: 32.5007, lon: -94.74049, locations facility: Washington Cntr Weight Mgmt, status: RECRUITING, city: Arlington, state: Virginia, zip: 22206, country: United States, geoPoint lat: 38.88101, lon: -77.10428, locations facility: Health Res of Hampton Roads, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, 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: National Clin Res Inc., status: RECRUITING, city: Richmond, state: Virginia, zip: 23294, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Paratus Clinical, status: NOT_YET_RECRUITING, city: Blacktown, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Northern Beaches Clinical Research, status: RECRUITING, city: Brookvale, state: New South Wales, zip: 2100, country: Australia, geoPoint lat: -33.76108, lon: 151.27446, locations facility: Holdsworth House Clinical Research, status: RECRUITING, city: Darlinghurst, state: New South Wales, zip: 2010, country: Australia, geoPoint lat: -33.87939, lon: 151.21925, locations facility: Novatrials, status: RECRUITING, city: Kotara, state: New South Wales, zip: 2289, country: Australia, geoPoint lat: -32.95, lon: 151.68333, locations facility: Paratus Clinical, status: NOT_YET_RECRUITING, city: Herston, state: Queensland, zip: 4006, country: Australia, geoPoint lat: -27.44453, lon: 153.01852, locations facility: University of Sunshine Coast, status: RECRUITING, city: Sippy Downs, state: Queensland, zip: 4556, country: Australia, geoPoint lat: -26.71793, lon: 153.05475, locations facility: CMAX Clinical Research, status: NOT_YET_RECRUITING, city: Norwood, state: South Australia, zip: 5067, country: Australia, geoPoint lat: -34.66667, lon: 149.73333, locations facility: Emeritus Research Melbourne, status: NOT_YET_RECRUITING, city: Camberwell, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.84205, lon: 145.0694, locations facility: Austin Health, Metabolic Disorders Centre, status: RECRUITING, city: Heidelberg Heights, state: Victoria, zip: 3081, country: Australia, geoPoint lat: -37.74313, lon: 145.05695, locations facility: Linear Clinical Research, status: WITHDRAWN, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, geoPoint lat: -31.98184, lon: 115.8073, locations facility: OCROM Clinic, status: RECRUITING, city: Suita-shi, state: Osaka, zip: 565-0853, country: Japan, geoPoint lat: 34.76143, lon: 135.51567, locations facility: ToCROM Clinic, status: RECRUITING, city: Tokyo, zip: 160-0008, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False