Healthy Volunteers Type 2 DiabetesPhase 1NCT06642584
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
A Phase 1 study testing Semaglutide B, Semaglutide J and Semaglutide L in people with Healthy Volunteers Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. 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 Volunteers Type 2 Diabetes
- What is being tested?
- Semaglutide B, Semaglutide J and Semaglutide L
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2024to 13 Aug 2025
- 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
- Male.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (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 (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study interventions or related products.
- Any condition 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 prior to first dosing.
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
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
- Conditions
- Healthy Volunteers Type 2 Diabetes
- Being tested
- Semaglutide B, Semaglutide J, Semaglutide L, Semaglutide M, Semaglutide N
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide BDrug
Semaglutide B will be administered subcutaneously.
Semaglutide JDrug
Semaglutide J will be administered as oral tablets.
Semaglutide LDrug
Semaglutide L will be administered as oral tablets.
Semaglutide MDrug
Semaglutide M will be administered as oral tablets.
Semaglutide NDrug
Semaglutide N will be administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide L | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide L |
| Sequence 2: Semaglutide L then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide L |
| Sequence 3: Semaglutide J then Semaglutide M | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide M |
| Sequence 4: Semaglutide M then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide M |
| Sequence 5: Semaglutide J then Semaglutide N | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide N |
| Sequence 6: Semaglutide N then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2. Receives: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
Measured in hours nanomoles per liter (h * nmol/L).
Measured: From 0 to 24 hours after dosing on Days 122 and 132.
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
Measured in nanomoles per liter(nmol/L).
Measured: From 0 to 24 hours after dosing on Days 122 and 132.
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
Measured in hours.
Measured: From 0 to 24 hours after dosing on Days 122 and 132.
t½,sema; the terminal half-life of semaglutide
Measured in hours.
Measured: From 0 to 840 hours after dosing on Day 132.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion10 Jul 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Type 2 DiabetesStudies 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
- 90 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
- NCT06642584
- Sponsor's protocol ID
- NN9501-5006
- Other IDs
- U1111-1304-9627
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2024
- Last updated
- 20 Oct 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 20 Oct 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
- ClinicalTrials.gov ID
- NCT06642584
- Acronym / sponsor ID
- NN9501-5006
- Conditions
- Healthy Volunteers Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 15 Oct 2024 (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.
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide L | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide LParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. |
| Sequence 2: Semaglutide L then Semaglutide J | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide LParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. |
| Sequence 3: Semaglutide J then Semaglutide M | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide MParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. |
| Sequence 4: Semaglutide M then Semaglutide J | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide MParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. |
| Sequence 5: Semaglutide J then Semaglutide N | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide NParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. |
| Sequence 6: Semaglutide N then Semaglutide J | Experimental | Drug: Semaglutide B, Drug: Semaglutide J, Drug: Semaglutide NParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then 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 (4 listed)
- Male.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (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 (ECG) 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 interventions or related products.
- Any condition 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 prior to first dosing.
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 |
|---|---|---|
| Semaglutide BSemaglutide B will be administered subcutaneously. | Drug | Sequence 1: Semaglutide J then Semaglutide L, Sequence 2: Semaglutide L then Semaglutide J, Sequence 3: Semaglutide J then Semaglutide M, Sequence 4: Semaglutide M then Semaglutide J, Sequence 5: Semaglutide J then Semaglutide N, Sequence 6: Semaglutide N then Semaglutide J |
| Semaglutide JSemaglutide J will be administered as oral tablets. | Drug | Sequence 1: Semaglutide J then Semaglutide L, Sequence 2: Semaglutide L then Semaglutide J, Sequence 3: Semaglutide J then Semaglutide M, Sequence 4: Semaglutide M then Semaglutide J, Sequence 5: Semaglutide J then Semaglutide N, Sequence 6: Semaglutide N then Semaglutide J |
| Semaglutide LSemaglutide L will be administered as oral tablets. | Drug | Sequence 1: Semaglutide J then Semaglutide L, Sequence 2: Semaglutide L then Semaglutide J |
| Semaglutide MSemaglutide M will be administered as oral tablets. | Drug | Sequence 3: Semaglutide J then Semaglutide M, Sequence 4: Semaglutide M then Semaglutide J |
| Semaglutide NSemaglutide N will be administered as oral tablets. | Drug | Sequence 5: Semaglutide J then Semaglutide N, Sequence 6: Semaglutide N then Semaglutide J |
Primary outcome
Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
Time frame: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in hours nanomoles per liter (h * nmol/L).
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
Time frame: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in nanomoles per liter(nmol/L).
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
Time frame: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in hours.
t½,sema; the terminal half-life of semaglutide
Time frame: From 0 to 840 hours after dosing on Day 132.
Measured in hours.
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 20 Oct 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 B, Semaglutide J and Semaglutide L in people with Healthy Volunteers Type 2 Diabetes, 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 4 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 20 Oct 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 AUC(sema); adjusted area under the semaglutide plasma concentration-time curve (time frame: From 0 to 24 hours after dosing on Days 122 and 132.). The study lists 4 primary outcomes in all. 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 20 Oct 2025.