Obesity
Conditions
Brief summary
This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.
Interventions
DRUGNNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
DRUGNNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of non-childbearing potential. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m\^2) and 39.9 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
* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) not reaching systemic circulation, within 14 days before screening. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS) | From pre-dose up to 7 days post-dose | Measured in hours\*nanomoles per liter (h\*nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state | From pre-dose up to 7 days post-dose | Measured in nanomoles per liter (nmol/L). |
| Number of adverse events | From time of first dosing (day 1) until completion of the end of study visit (day 141/162) | Measured in number of events. |
Countries
United States
Outcome results
None listed