Obesity, Overweight
Conditions
Brief summary
The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.
Interventions
DRUGNNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
DRUGPlacebo
Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. 4. 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 and visit 2, day -1, as judged by the investigator.
Exclusion criteria
1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 3. Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) \[48 millimole per mole (mmol/mol)\] at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From time of dosing (day 1) up to day 43 | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC: Area under the NNC0113-5840 plasma concentration time-curve | From pre-dose (day 1) up to day 43 | Measured as hours\*nanomole per liter (h\*nmol/L) |
| Cmax: Maximum observed NNC0113-5840 plasma concentration | From pre-dose (day 1) up to day 43 | Measured as nanomoles per liter (nmol/L) |
Countries
United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed