Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
NNC0519-0130 will be administered subcutaneously.
Placebo matched to NNC0519-0130 will be administered subcutaneously.
Peking University Third Hospital, Northern Branch-Phase I
Beijing, Beijing Municipality, China
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
Measured in hours\*nanomoles per liter (h\*nmol/L).
Time frame: From pre-dose up to 7 days post-dose
Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period
Measured in nanomoles per liter (nmol/L).
Time frame: From pre-dose up to 7 days post-dose
t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose
Measured in hours (h).
Time frame: From pre-dose until completion of the follow-up visit (day 162)
Number of treatment emergent adverse events (TEAEs)
Measured in number of events.
Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 162)
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