Healthy Volunteers, Obesity, Overweight
Conditions
Brief summary
The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Interventions
DRUGSemaglutide
Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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
Yes
Inclusion criteria
* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 and 27.0 kg/m\^2 (both inclusive).
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. * Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the semaglutide plasma concentration curve from 0 to tz | 0-840 hours | h\*nmol/L |
| Maximum semaglutide plasma concentration | 0-840 hours | nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution of semaglutide | 0-840 hours | L |
| Area under the semaglutide plasma concentration curve | 0-840 hours | h\*nmol/L |
| Time to Cmax for semaglutide | 0-840 hours | h |
| Terminal elimination half-life | 0-840 hours | h |
| Total apparent clearance of semaglutide | 0-840 hours | L/h |
Countries
Germany
Outcome results
None listed