This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body. Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance. NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Novo Nordisk Investigational Site
Overland Park, Kansas, United States
Number of treatment emergent adverse events (TEAEs)
Count of events
Time frame: Day 1-110
The area under the NNC9204-1177 serum concentration-time curve at steady state
Calculated based on NNC9204-1177 measured in blood.
Time frame: 0-168 hours
The maximum serum concentration of NNC9204-1177 at steady state
Calculated based on NNC9204-1177 measured in blood.
Time frame: Day 78-110
The time to maximum serum concentration of NNC9204-1177
Calculated based on NNC9204-1177 measured in blood.
Time frame: Day 78-110
The terminal half-life of NNC9204-1177 from steady state
Calculated based on NNC9204-1177 measured in blood.
Time frame: Day 78-110
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