nctId: NCT06326047 id: NN9541-4945 id: U1111-1291-9196 type: OTHER domain: World Health Organization (WHO) 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 overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-08-26 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY 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. conditions: Diabetes Mellitus, Type 2 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. 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 count: 288 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Trizepatide measure: Change in Glycated haemoglobin (HbA1c) measure: Change in Glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Change in body weight measure: Change in fasting plasma glucose (FPG) 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)) measure: Change in waist circumference 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: Number of adverse events sex: ALL 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