A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide
|
Drug: Semaglutide D Dose 1
Tablet given orally
Drug: Semaglutide D Dose 2
Tablet given orally
Drug: Semaglutide D Dose 3
Tablet given orally
Drug: Semaglutide C Dose 4
Tablet given orally
Drug: Semaglutide C Dose 5 (50 mg)
Tablet given orally
|
| Placebo Comparator: Placebo
|
Drug: Placebo (Semaglutide C)
Tablet given orally
Drug: Placebo ( Semaglutide D)
Tablet given orally
|
Outcome Measures
Primary Outcome Measures
- Relative change in energy intake during ad libitum lunch [Baseline to Day 140]
Measured in Percentage
Secondary Outcome Measures
- Change in energy intake during ad libitum lunch [Baseline to Day 140]
Measured in kJ
- Change in amount of food consumed during ad libitum lunch [Baseline to Day 140]
Measured in g
- Change in body weight [Baseline to Day 141]
Measured in Percentage
- AUC0-5h,para [0-5h after standardised meal, Day 141]
Measured in h*mg/mL
- AUC0-1h,para [0-1h after standardised meal, Day 141]
Measured in h*mg/mL
- Cmax,para [0-5h after standardised meal, Day 141]
Measured in μg/mL
- tmax,para [0-5h after standardised meal, Day 141]
Measured in h
- Mean postprandial rating - hunger [Day 140]
Measured in mm
- Mean postprandial rating - fullness [Day 140]
Measured in mm
- Mean postprandial rating - satiety [Day 140]
Measured in mm
- Mean postprandial rating - prospective food consumption [Day 140]
Measured in mm
- Mean postprandial rating - overall appetite score (OAS) [Day 140]
Measured in mm
- Food cravings assessed by Control of Eating Questionnaire (COEQ) [Day 139]
Measured in mm
- AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state [Day 140 to 141]
Measured in nmol*h/L
- Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg [Day 140 to 175]
Measured in nmol*h/L
- tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg [Day 140 to 175]
Measured in h
- t½,sema,50mg,SS terminal half-life of the log concentration time curve [Day 140 to 175]
Measured in h
- CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state [Day 140 to 175]
Measured in L/h
- Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state [Day 140 to 175]
Measured in L
- Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg [Day 140 to 175]
Measured in L
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Berlin | Germany | 14050 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9932-4873
- 2021-003341-38
- U1111-1266-4375