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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Parexel International GmbH
Berlin, Germany
Relative change in energy intake during ad libitum lunch
Measured in Percentage
Time frame: Baseline to Day 140
Change in energy intake during ad libitum lunch
Measured in kJ
Time frame: Baseline to Day 140
Change in amount of food consumed during ad libitum lunch
Measured in g
Time frame: Baseline to Day 140
Change in body weight
Measured in Percentage
Time frame: Baseline to Day 141
AUC0-5h,para
Measured in h\*μg/mL
Time frame: 0-5h after standardised meal, Day 141
AUC0-1h,para
Measured in h\*μg/mL
Time frame: 0-1h after standardised meal, Day 141
Cmax,para
Measured in μg/mL
Time frame: 0-5h after standardised meal, Day 141
tmax,para
Measured in h
Time frame: 0-5h after standardised meal, Day 141
Mean postprandial rating - hunger
Measured in mm
Time frame: Day 140
Mean postprandial rating - fullness
Measured in mm
Time frame: Day 140
Mean postprandial rating - satiety
Measured in mm
Time frame: Day 140
Mean postprandial rating - prospective food consumption
Measured in mm
Time frame: Day 140
Mean postprandial rating - overall appetite score (OAS)
Measured in mm
Time frame: Day 140
Food cravings assessed by Control of Eating Questionnaire (COEQ)
Measured in mm
Time frame: 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
Time frame: Day 140 to 141
Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg
Measured in nmol\*h/L
Time frame: 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
Time frame: Day 140 to 175
t½,sema,50mg,SS terminal half-life of the log concentration time curve
Measured in h
Time frame: Day 140 to 175
CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state
Measured in L/h
Time frame: Day 140 to 175
Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state
Measured in L
Time frame: Day 140 to 175
Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg
Measured in L
Time frame: Day 140 to 175
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