Healthy ParticipantsPhase 1NCT06097390
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
A Phase 1 study testing Semaglutide in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. 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 siteCanada
- Study dates
- 28 Sep 2023to 27 Mar 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 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- 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
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide K | Experimental | Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2. Receives: Drug: Semaglutide |
| Sequence 2: Semagultide K then Semaglutide J | Experimental | Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
Measured in hour*nanomoles per liter (h*nmol/L).
Measured: From 0 to 24 hours after dosing on day 80 and 90
Secondary outcomes (3)
Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
Measured in nanomoles per liter (nmol/L).
Measured: From 0 to 24 hours after dosing on day 80 and 90
Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
Measured in hours.
Measured: From 0 to 24 hours after dosing on day 80 and 90
t½,sema; the terminal half-life of semaglutide
Measured in hours.
Measured: From 0 to 840 hours after dosing on day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start28 Sep 2023
- Primary completion22 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097390
- Sponsor's protocol ID
- NN9501-4924
- Other IDs
- U1111-1289-1040
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2023
- Last updated
- 17 Jul 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
- ClinicalTrials.gov ID
- NCT06097390
- Acronym / sponsor ID
- NN9501-4924
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide K | Experimental | Drug: SemaglutideOral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2. |
| Sequence 2: Semagultide K then Semaglutide J | Experimental | Drug: SemaglutideOral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- 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.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideOral administration | Drug | Sequence 1: Semaglutide J then Semaglutide K, Sequence 2: Semagultide K then Semaglutide J |
Primary outcome
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
Time frame: From 0 to 24 hours after dosing on day 80 and 90
Measured in hour*nanomoles per liter (h*nmol/L).
3 secondary outcomes
Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
Time frame: From 0 to 24 hours after dosing on day 80 and 90
Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
Time frame: From 0 to 24 hours after dosing on day 80 and 90
t½,sema; the terminal half-life of semaglutide
Time frame: From 0 to 840 hours after dosing on day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
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 Canada.
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 17 Jul 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 Canada. 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?
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve (time frame: From 0 to 24 hours after dosing on day 80 and 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.