A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

Study Overview
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Brief Summary
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This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal. In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks. The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.

Official Title
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The Effect of Oral Semaglutide 50 mg Once-daily on Energy Intake, Gastric Emptying, Appetite, Control of Eating and Pharmacokinetics in Participants With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Drug: Semaglutide D Dose 1
* Drug: Semaglutide D Dose 2
* Drug: Semaglutide D Dose 3
* Drug: Semaglutide C Dose 4
* Drug: Semaglutide C Dose 5 (50 mg)
* Drug: Placebo (Semaglutide C)
* Drug: Placebo ( Semaglutide D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent Body mass index between 30.0 and 45.0 kilogram per meter square (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 participant 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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Accepts Healthy Volunteers

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> | Drug: Semaglutide D Dose 1<br>* Tablet given orally<br>Drug: Semaglutide D Dose 2<br>* Tablet given orally<br>Drug: Semaglutide D Dose 3<br>* Tablet given orally<br>Drug: Semaglutide C Dose 4<br>* Tablet given orally<br>Drug: Semaglutide C Dose 5 (50 mg)<br>* Tablet given orally<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo (Semaglutide C)<br>* Tablet given orally<br>Drug: Placebo ( Semaglutide D)<br>* Tablet given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in energy intake during ad libitum lunch | Measured in Percentage | Baseline to Day 140 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy intake during ad libitum lunch | Measured in kJ | Baseline to Day 140 | 
| Change in amount of food consumed during ad libitum lunch | Measured in g | Baseline to Day 140 | 
| Change in body weight | Measured in Percentage | Baseline to Day 141 | 
| AUC0-5h,para | Measured in h*μg/mL | 0-5h after standardised meal, Day 141 | 
| AUC0-1h,para | Measured in h*μg/mL | 0-1h after standardised meal, Day 141 | 
| Cmax,para | Measured in μg/mL | 0-5h after standardised meal, Day 141 | 
| tmax,para | Measured in h | 0-5h after standardised meal, Day 141 | 
| Mean postprandial rating - hunger | Measured in mm | Day 140 | 
| Mean postprandial rating - fullness | Measured in mm | Day 140 | 
| Mean postprandial rating - satiety | Measured in mm | Day 140 | 
| Mean postprandial rating - prospective food consumption | Measured in mm | Day 140 | 
| Mean postprandial rating - overall appetite score (OAS) | Measured in mm | Day 140 | 
| Food cravings assessed by Control of Eating Questionnaire (COEQ) | Measured in mm | Day 139 | 
| AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state | Measured in nmol*h/L | Day 140 to 141 | 
| Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg | Measured in nmol*h/L | Day 140 to 175 | 
| tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg | Measured in h | Day 140 to 175 | 
| t½,sema,50mg,SS terminal half-life of the log concentration time curve | Measured in h | Day 140 to 175 | 
| CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state | Measured in L/h | Day 140 to 175 | 
| Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state | Measured in L | Day 140 to 175 | 
| Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg | Measured in L | Day 140 to 175 |