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

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (Semaglutide C); Tablet given orally; Drug: Placebo ( Semaglutide D); Tablet given orally
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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NN9932-4873; 2021-003341-38 (EudraCT Number); U1111-1266-4375 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No