Healthy Volunteers, Obesity, Overweight, Type 1 Diabetes (T1D)
Conditions
Brief summary
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
Interventions
DRUGNNC0497-0040
NNC0497-0040 will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
For SAD cohorts Inclusion Criteria: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening. * Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per m\^2 (both inclusive) at screening. * Considered to be generally 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 participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening. * Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing. For MAD1-3 cohorts Inclusion Criteria: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening. * Body mass index between 27.0 kilogram per m\^2 and 39.9 kilogram per 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Day 1 up to Week 6 | Measured in events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum NNC0497-0040 concentration time curve | Day 1 | Measured in hours \* nanomoles per litre (h\*nmol/L) |
| Cmax: Maximum observed serum NNC0497-0040 concentration | Day 1 | Measured in nanomoles per litre (nmol/L) |
| Area under the serum NNC0497-0040 concentration time curve at steady state | MAD1-2: Week 12; MAD3: Week 20 | Measured in hours \* nanomoles per litre (h\*nmol/L) |
| Cmax: Maximum observed serum NNC0497-0040 concentration at steady state | MAD1-2: Week 12; MAD3: Week 20 | Measured in nanomoles per litre (nmol/L) |
| Number of severe hypoglycaemic episodes | Day 1 up to Week 25 | Measured in events |
| AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state | MAD4: Week 20 | Measured in hours \* nanomoles per litre (h\*nmol/L) |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed