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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236517
• Other study ID #: NN9932-4873
• Secondary ID: 2021-003341-38U1
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: September 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 7, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide D Dose 1
Tablet given orally
• Semaglutide D Dose 2
Tablet given orally
• Semaglutide D Dose 3
Tablet given orally
• Semaglutide C Dose 4
Tablet given orally
• Semaglutide C Dose 5 (50 mg)
Tablet given orally
• Placebo (Semaglutide C)
Tablet given orally
• Placebo ( Semaglutide D)
Tablet given orally

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

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