diabetes
Conditions
Interventions
NNC0480-0389 (1.7, 8.6, 43 or 60 mg) and/or semaglutide (0.5 mg) and/or
placebo will be given as injections subcutaneous.
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: SAD part - Male aged 18-45 years (both inclusive) at the time of signing informed consent. - BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive). MAD part (not applicable for PoC cohort) - BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive). - Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. MAD part (only applicable for PoC cohort) - BMI between 25.0 kg/m2 and 39.9 kg/m2 (both inclusive). Overweight or obesity should be due to excess adipose tissue, as judged by the investigator. -Female of non-childbearing potential or male aged 18-64 years (both inclusive) at the time of signing informed consent. -Subjects treated with diet and exercise as monotherapy or in combination with 1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30 days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin dose should be >= 1500 mg to
Exclusion criteria
Exclusion criteria: - Any disorder (except for conditions associated with T2D for the PoC cohort included in the MAD part) which in the investigator*s opinion might jeopardise subject*s safety or compliance with the protocol. - HbA1c >= 6.5 % (48 mmol/mol) at screening (except for MAD part only applicable for PoC cohort). - Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening (except for the MAD part only applicable for PoC cohort).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAD part To investigate the safety and tolerability of single doses of NNC0480-0389 subcutaneously coadministered with semaglutide in healthy male subjects. MAD part To investigate the safety and tolerability of multiple doses of NNC0480-0389 subcutaneously co-administered with semaglutide in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| SAD part To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous co-administration of single doses of NNC0480-0389 and semaglutide in healthy male subjects MAD part: To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous co-administration of multiple doses of NNC0480-0389 and semaglutide in healthy subjects MAD/POC part To investigate the safety and tolerability of multiple doses of NNC0480-0389 subcutaneously co-administered with semaglutide in subjects with type 2 diabetes To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous co-administration of multiple doses of NNC0480-0389 and semaglutide in subjects with type 2 diabetes | — |
Countries
Netherlands
Outcome results
None listed