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AzTrials

ObesityPhase 1NCT05236517

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

A Phase 1 study testing Semaglutide D Dose 1, Semaglutide D Dose 2 and Semaglutide D Dose 3 in people with Obesity, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Semaglutide D Dose 1, Semaglutide D Dose 2 and Semaglutide D Dose 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteGermany
Study dates
8 Feb 2022to 7 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Parexel International GmbH

    Berlin, 14050

Other trials in Germany

About this study

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

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.

Conditions
Obesity
Being tested
Semaglutide D Dose 1, Semaglutide D Dose 2, Semaglutide D Dose 3, Semaglutide C Dose 4, Semaglutide C Dose 5 (50 mg)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide D Dose 1Drug

    Tablet given orally

  • Semaglutide D Dose 2Drug

    Tablet given orally

  • Semaglutide D Dose 3Drug

    Tablet given orally

  • Semaglutide C Dose 4Drug

    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

Study groups in NCT05236517
Study groupRoleWhat they receive
SemaglutideExperimentalNot described
Receives: 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)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo (Semaglutide C); Drug: Placebo ( Semaglutide D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in energy intake during ad libitum lunch

    Measured in Percentage

    Measured: Baseline to Day 140

Secondary outcomes (20)

  1. Change in energy intake during ad libitum lunch

    Measured in kJ

    Measured: Baseline to Day 140

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

    Measured in g

    Measured: Baseline to Day 140

  3. Change in body weight

    Measured in Percentage

    Measured: Baseline to Day 141

  4. AUC0-5h,para

    Measured in h*μg/mL

    Measured: 0-5h after standardised meal, Day 141

  5. AUC0-1h,para

    Measured in h*μg/mL

    Measured: 0-1h after standardised meal, Day 141

  6. Cmax,para

    Measured in μg/mL

    Measured: 0-5h after standardised meal, Day 141

  7. tmax,para

    Measured in h

    Measured: 0-5h after standardised meal, Day 141

  8. Mean postprandial rating - hunger

    Measured in mm

    Measured: Day 140

  9. Mean postprandial rating - fullness

    Measured in mm

    Measured: Day 140

  10. Mean postprandial rating - satiety

    Measured in mm

    Measured: Day 140

  11. Mean postprandial rating - prospective food consumption

    Measured in mm

    Measured: Day 140

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

    Measured in mm

    Measured: Day 140

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

    Measured in mm

    Measured: Day 139

  14. 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

    Measured: Day 140 to 141

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

    Measured in nmol*h/L

    Measured: Day 140 to 175

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

    Measured in h

    Measured: Day 140 to 175

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

    Measured in h

    Measured: Day 140 to 175

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

    Measured in L/h

    Measured: Day 140 to 175

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

    Measured in L

    Measured: Day 140 to 175

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

    Measured in L

    Measured: Day 140 to 175

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start8 Feb 2022
  3. Primary completion29 Sep 2022
  4. Study completion7 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236517
Sponsor's protocol ID
NN9932-4873
Other IDs
2021-003341-38, U1111-1266-4375
Status last verified
Sep 2024
First submitted
4 Feb 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Gabe MBN, Breitschaft A, Knop FK, Hansen MR, Kirkeby K, Rathor N, Adrian CL. Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31.

    PubMed 39082206

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide D Dose 1, Semaglutide D Dose 2 and Semaglutide D Dose 3 in people with Obesity, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in energy intake during ad libitum lunch (time frame: Baseline to Day 140). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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