Skip to content

Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05236517 (opens ClinicalTrials.gov in a new tab)Other idNN9932-4873Other id2021-003341-38Other idU1111-1266-4375
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
60 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
8 Feb 2022
Primary completion
29 Sept 2022
Completion
7 Nov 2022
First posted
11 Feb 2022
Last update posted
19 Sept 2024
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. Ph 1

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

    NCT05236517

    8 Feb 2022 to 7 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms2

  • Experimental

    Semaglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in energy intake during ad libitum lunch

    Time frame · Baseline to Day 140

    Registry description

    Measured in Percentage

Secondary outcomes(20)

  1. Change in energy intake during ad libitum lunch

    Time frame · Baseline to Day 140

    Registry description

    Measured in kJ

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

    Time frame · Baseline to Day 140

    Registry description

    Measured in g

  3. Change in body weight

    Time frame · Baseline to Day 141

    Registry description

    Measured in Percentage

  4. AUC0-5h,para

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

    Registry description

    Measured in h\*μg/mL

  5. AUC0-1h,para

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

    Registry description

    Measured in h\*μg/mL

  6. Cmax,para

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

    Registry description

    Measured in μg/mL

  7. tmax,para

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

    Registry description

    Measured in h

  8. Mean postprandial rating - hunger

    Time frame · Day 140

    Registry description

    Measured in mm

  9. Mean postprandial rating - fullness

    Time frame · Day 140

    Registry description

    Measured in mm

  10. Mean postprandial rating - satiety

    Time frame · Day 140

    Registry description

    Measured in mm

  11. Mean postprandial rating - prospective food consumption

    Time frame · Day 140

    Registry description

    Measured in mm

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

    Time frame · Day 140

    Registry description

    Measured in mm

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

    Time frame · Day 139

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Measured in h

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

    Time frame · Day 140 to 175

    Registry description

    Measured in h

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

    Time frame · Day 140 to 175

    Registry description

    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

    Registry description

    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

    Registry description

    Measured in L

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

8 results

Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial.

Gabe et al. 2024Diabetes, obesity & metabolismcited by 36

PMID 39082206DOI 10.1111/dom.15802PUB-39082206

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.