A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
NNC0519-0130 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Parexel International GmbH
Berlin, Germany
Number of adverse events
Measured in number of events.
Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 274/253)
Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI)
Measured in milliseconds (ms).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
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