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Clinical Trial Details

Trial ID: L4239
Source ID: NCT06567041
Associated Drug: Nnc0519-0130
Title: A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: NNC0519-0130|DRUG: Placebo
Outcome Measures: Primary: Number of adverse events, Measured in number of events., From time of first dosing (day 1) until completion of the end of study visit (day 274/253) | Secondary: Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI), Measured in milliseconds (ms)., From baseline (day - 1) until completion of the end of study visit (day 274/253)|Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF), Measured in ms., From baseline (day - 1) until completion of the end of study visit (day 274/253)|Area under the NNC0519-0130 plasma concentration-time curve in steady state, Measured in hours\*nanomoles per liter (h\*nmol/L)., From pre-dose until 7 days post-dose, for third and last doses in the maintenance period|Maximum plasma concentration of NNC0519-0130 in steady state, Measured in nanomoles per liter (nmol/L)., From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2025-12-03
Results First Posted:
Last Update Posted: 2025-04-10
Locations: Parexel International GmbH, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT06567041

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress