Diabetes Mellitus, Type 2, 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 excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
Interventions
DRUGNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
DRUGPlacebo
Placebo matched to NNC0519-0130 will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male Chinese participant. * Body Mass Index (BMI) between 24.0 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 (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * 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 (including Chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), domperidone or topical medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period | 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 after the last dose in each treatment period | From pre-dose up to 7 days post-dose | Measured in nanomoles per liter (nmol/L). |
| t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose | From pre-dose until completion of the follow-up visit (day 162) | Measured in hours (h). |
| Number of treatment emergent adverse events (TEAEs) | From time of first dosing (day 1) until completion of the end of study visit (day 162) | Measured in number of events. |
Countries
China
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed