type 2 diabetes
Conditions
Interventions
- 28-day screening period.
- Dose escalation every three weeks is applied and four dose levels (NNC0519-0130 5 mg, 12 mg, 25 mg, 50 mg) or placebo will be tested.
- 24 participants within each race gr
Sponsors
Tsukasaki Nobuaki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Body mass index (BMI) between 23.0 kg/m2 and 39.9 kg/m2 (both inclusive) at screening with a minimum weight of 50 kg. 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
Exclusion criteria: - Any disorder, which in the investigator opinion might jeopardise safety of participant or compliance with the protocol. - Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, GI, or endocrinological conditions. - HbA1c >= 6.5 % (48 mmol/mol) at screening. -Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period - Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period - Terminal half-life of NNC0519-0130 after the last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | — |
Contacts
Public ContactNobuaki Tsukasaki
Novo Nordisk Pharma Ltd.
Outcome results
None listed