Obesity, Overweight
Conditions
Brief summary
This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a dummy medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.
Interventions
DRUGNNC0662-0419
Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.
OTHERPlacebo (NNC0662-0419)
Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (sex at birth) * Aged 19-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible 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.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening. * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening. * Calcitonin \>= 50 nanogram per liter (ng/L) at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAE) | From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks) | Number of events |
| Part B: Number of treatment-emergent adverse events (TEAE) | From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks) | Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve | From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks) | measured in hour\*nanomoles per liter (h\*nmol/L) |
| Part A: Cmax; the maximum plasma concentration of NNC0662-0419 | From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks) | measured in nanomoles per liter(nmol/L) |
| Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve | From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks) | measured in h\*nmol/L |
| Part B: Cmax; the maximum plasma concentration of NNC0662-0419 | From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks) | measured in nmol/L |
Countries
United States
Outcome results
None listed