nctId: NCT06326060 id: NN9541-5015 id: U1111-1291-9210 type: OTHER domain: World Health Organization (WHO) 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 overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-05-05 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY 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. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 343 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Tirzepatide measure: Relative change in body weight measure: Change in body weight measure: Achievement of greater than equal to (≥) 5% weight reduction measure: Achievement of ≥ 10% weight reduction measure: Achievement of ≥ 15% weight reduction measure: Achievement of ≥ 20% weight reduction measure: Change in body mass index (BMI) measure: Change in waist circumference measure: Change in glycated hemoglobin (HbA1c) measure: Change in fasting plasma glucose (FPG) measure: Change in systolic blood pressure (SBP) measure: Change in high sensitivity C-Reactive protein (hsCRP) measure: Change in total cholesterol measure: Change in high-density lipoprotein (HDL) cholesterol measure: Change in low-density lipoprotein (LDL) cholesterol measure: Change in triglycerides measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score measure: Change in IWQOL-Lite-CT Psychosocial composite score measure: Change in IWQOL-Lite-CT Physical Function score measure: Change in IWQOL-Lite-CT Total score measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centricity Research-Arizona status: WITHDRAWN city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Arkansas Clinical Research status: WITHDRAWN city: Little Rock state: Arkansas zip: 72205 country: United States lat: 34.74648 lon: -92.28959 facility: Unity Health-Searcy Medical Center status: RECRUITING city: Searcy state: Arkansas zip: 72143 country: United States lat: 35.25064 lon: -91.73625 facility: FDRC status: RECRUITING city: Costa Mesa state: California zip: 92627 country: United States lat: 33.64113 lon: -117.91867 facility: Diablo Clinical Research, Inc. status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States lat: 37.90631 lon: -122.06496 facility: Univ of Colorado at Denver status: WITHDRAWN city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Jacksonville Ctr For Clin Res status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Midwest Inst For Clin Res status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: Velocity Clin. 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