The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.
ICON Early Phase Services, LLC
Lenexa, Kansas, United States
ICON
San Antonio, Texas, United States
ICON-Salt Lake City
Salt Lake City, Utah, United States
ICON - location Groningen
Groningen, Netherlands
Part A: Number of treatment emergent adverse events (TEAE)
Measured as Number of events
Time frame: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
Measured as Number of events
Time frame: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
Measured in hours\*nano mole per litre (h\*nmol/L)
Time frame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
Measured in nano mole per litre (nmol/L)
Time frame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
Measured in hour\*nano mole per litre (h\*nmol/L)
Time frame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration
Measured in nano mole per litre (nmol/L)
Time frame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
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