Obesity
Conditions
Brief summary
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.
Interventions
DRUGNNC0519-0130
Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Female of non-childbearing potential, or male. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 44.9 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 to be otherwise 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.
Exclusion criteria
* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication 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 |
|---|---|---|
| Number of Adverse Events (AEs) | From randomisation (week 0) to week 18 | Measured as number of events. |
Countries
Austria
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed