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Healthy ParticipantsPhase 1NCT05996874

A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants

A Phase 1 study testing Semaglutide in people with Healthy Participants, 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

In this study, a known medicine called 'semaglutide' will be tested in a new tablet version. The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration. Read more about this study

Who is it for?
Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteGermany
Study dates
12 Aug 2023to 18 Apr 2024
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 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m^2) (both inclusive)
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Who cannot join

  • Glycated Hemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening
  • Use of tobacco and nicotine products, defined as any of the below:
  • Smoking more than 5 cigarettes or the equivalent per day
  • Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: Investigation of the Effect of Dosing Conditions on the Pharmacokinetics of New Oral Semaglutide Formulation in Healthy Participants

In this study, a known medicine called 'semaglutide' will be tested in a new tablet version. The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration. Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the treatment of type 2 diabetes. Participants will get a daily treatment with dose 1 new oral semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new oral semaglutide tablet. Participants will get one tablet each day for 10 days. The tablet should be taken in the morning on an empty stomach with either 50 milliliter (mL) or 120mL water, after an overnight fast of at least 6 hours (no food or drinks). Water is not allowed from 2 hours before dosing. A predefined breakfast will be served either 30, 60 or 120 minutes after taking tablet, depending on the treatment received. Breakfast will need to be eaten within 30 minutes. Which treatment participants will get is decided by chance. The study will last for about 11 weeks. This will include a screening period (up to 28 days), a treatment period (10 days) and a follow-up visit (at least 5 weeks after the last dose). Participants should not take any prescription or non-prescription medicines or herbal products (including St John's wort) within 14 days prior to the screening visit and until the follow-up visit, except for routine vitamins, medicines applied on the skin and occasional use of paracetamol (a mild pain killer). No oral medication can be taken from 2 hours before and, depending on the group participants are in, until 30, 60 or 120 minutes after each dosing with semaglutide.

Being tested
Semaglutide

What participants receive

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

  • SemaglutideDrug

    Participants will receive Dose 1 oral semaglutide D for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days.

Study groups in NCT05996874
Study groupRoleWhat they receive
Semaglutide: 50 mL water and 30 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 30 minutes post-dose fasting.
Receives: Drug: Semaglutide
Semaglutide: 120 mL water and 30 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by dose 2 of oral semaglutide D for another 5 days with 120 mL water and 30 minutes post-dose fasting.
Receives: Drug: Semaglutide
Semaglutide: 50 mL water and 60 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 60 minutes post-dose fasting.
Receives: Drug: Semaglutide
Semaglutide: 120 mL water and 60 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 60 minutes post-dose fasting.
Receives: Drug: Semaglutide
Semaglutide: 50 mL water and 120 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 120 minutes post-dose fasting.
Receives: Drug: Semaglutide
Semaglutide: 120 mL water and 120 minutes post-dose fastingExperimentalParticipants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 120 minutes post-dose fasting.
Receives: Drug: Semaglutide

What is being measured

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

  1. AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing

    Measured in hour*nanomoles per liter (h*nmol/L).

    Measured: From 0 to 24 hours after dosing on day 10

Secondary outcomes (2)

  1. Cmax,0-24h,sema,Day10: Maximum semaglutide plasma concentration after the 10th dosing

    Measured in nanomoles per liter (nmol/L).

    Measured: From 0 to 24 hours after dosing on day 10

  2. tmax,0-24h,sema,Day10: Time to maximum semaglutide plasma concentration after the 10th dosing

    Measured in hours (h).

    Measured: From 0 to 24 hours after dosing on day 10

Timeline

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

  1. First posted18 Aug 2023
  2. Study start12 Aug 2023
  3. Primary completion18 Apr 2024
  4. Study completion18 Apr 2024

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
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996874
Sponsor's protocol ID
NN9924-4977
Other IDs
U1111-1281-4819, 2022-002848-52
Status last verified
Sep 2025
First submitted
10 Aug 2023
Last updated
24 Sep 2025
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide in people with Healthy Participants, 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 7 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 24 Sep 2025. 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. 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?

AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (time frame: From 0 to 24 hours after dosing on day 10). 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 NCT05996874.

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 24 Sep 2025.

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