About this trial
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
Body mass index between 18.5 kilogram per m² and 29.9 kilogram per m² (both inclusive) at screening.
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Disqualifiers
Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
Trial design
Sequential
Treatments tested in this trial
NNC0497-0040
DrugNNC0497-0040 will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
Treatment groups
Trial outcomes
Primary outcomes
Number of adverse events
Measured in events
Number of adverse events
Measured in events
Number of adverse events
Measured in events
Secondary outcomes
Area under the serum NNC0497-0040 concentration time curve
Measured in hours \* nanomoles per litre (h\*nmol/L)
Cmax: Maximum observed serum NNC0497-0040 concentration
Measured in nanomoles per litre (nmol/L)
Area under the serum NNC0497-0040 concentration time curve at steady state
Measured in hours \* nanomoles per litre (h\*nmol/L)
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Measured in nanomoles per litre (nmol/L)
Sponsors and contacts
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