Obesity, Overweight
Conditions
Brief summary
This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a dummy medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or dummy medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.
Interventions
DRUGSemaglutide
Participants will receive gradually increasing doses of semaglutide (subcutaneous \[s.c.\], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.
DRUGPlacebo
Participants will receive once weekly injections of semaglutide matched placebo.
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
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 30.0 and 45.0 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 a highly effective contraceptive method * Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state | 0 to 5 hours after standardised meal (day 142) | Measured in h\*micrograms/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours | 0 to 5 hours after standardised meal (day 142) | Measured in micrograms/mL |
| Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours | 0 to 5 hours after standardised meal (day 142) | Measured in hours |
| Energy intake during ad libitum lunch | Day 142 | Measured in kilojoules |
| Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal | Day 142 | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. |
| AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state | 0 to 1 hour after standardised meal (day 142) | Measured in h\*micrograms/mL |
| Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Day 142 | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. |
| Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Day 142 | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. |
| Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Day 142 | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. |
| Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Day 142 | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. |
Countries
Germany
Outcome results
None listed