Skip to main content
OpenTrials
Completed

NCT Number: NCT05236517

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide D Dose 1

Drug

Tablet given orally

Semaglutide D Dose 2

Drug

Tablet given orally

Semaglutide D Dose 3

Drug

Tablet given orally

Semaglutide C Dose 4

Drug

Tablet given orally

Semaglutide C Dose 5 (50 mg)

Drug

Tablet given orally

Placebo (Semaglutide C)

Drug

Tablet given orally

Placebo ( Semaglutide D)

Drug

Tablet given orally

Primary outcomes

  1. Relative change in energy intake during ad libitum lunch

    Time frame: Baseline to Day 140

    Measured in Percentage

Secondary outcomes

  1. Change in energy intake during ad libitum lunch

    Time frame: Baseline to Day 140

    Measured in kJ

  2. Change in amount of food consumed during ad libitum lunch

    Time frame: Baseline to Day 140

    Measured in g

  3. Change in body weight

    Time frame: Baseline to Day 141

    Measured in Percentage

  4. AUC0-5h,para

    Time frame: 0-5h after standardised meal, Day 141

    Measured in h*μg/mL

  5. AUC0-1h,para

    Time frame: 0-1h after standardised meal, Day 141

    Measured in h*μg/mL

  6. Cmax,para

    Time frame: 0-5h after standardised meal, Day 141

    Measured in μg/mL

  7. tmax,para

    Time frame: 0-5h after standardised meal, Day 141

    Measured in h

  8. Mean postprandial rating - hunger

    Time frame: Day 140

    Measured in mm

  9. Mean postprandial rating - fullness

    Time frame: Day 140

    Measured in mm

  10. Mean postprandial rating - satiety

    Time frame: Day 140

    Measured in mm

  11. Mean postprandial rating - prospective food consumption

    Time frame: Day 140

    Measured in mm

  12. Mean postprandial rating - overall appetite score (OAS)

    Time frame: Day 140

    Measured in mm

  13. Food cravings assessed by Control of Eating Questionnaire (COEQ)

    Time frame: Day 139

    Measured in mm

  14. AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state

    Time frame: Day 140 to 141

    Measured in nmol*h/L

  15. Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg

    Time frame: Day 140 to 175

    Measured in nmol*h/L

  16. tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg

    Time frame: Day 140 to 175

    Measured in h

  17. t½,sema,50mg,SS terminal half-life of the log concentration time curve

    Time frame: Day 140 to 175

    Measured in h

  18. CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state

    Time frame: Day 140 to 175

    Measured in L/h

  19. Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state

    Time frame: Day 140 to 175

    Measured in L

  20. Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg

    Time frame: Day 140 to 175

    Measured in L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.