A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: Semaglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide<br>Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks. | Drug: Semaglutide<br>* 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.<br>|
| Placebo Comparator: Placebo (Semaglutide)<br>Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks | Drug: Placebo<br>* Participants will receive once weekly injections of semaglutide matched placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state | Measured in h*micrograms/mL | 0 to 5 hours after standardised meal (day 142) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state | Measured in h*micrograms/mL | 0 to 1 hour after standardised meal (day 142) | 
| Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours | Measured in micrograms/mL | 0 to 5 hours after standardised meal (day 142) | 
| Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours | Measured in hours | 0 to 5 hours after standardised meal (day 142) | 
| Energy intake during ad libitum lunch | Measured in kilojoules | Day 142 | 
| Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 | 
| Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 | 
| Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 | 
| Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 | 
| Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |