Healthy ParticipantsPhase 1NCT05784402
A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants
A Phase 1 study testing Semaglutide J and Semaglutide C in people with Healthy Participants, run by Novo Nordisk A/S at 3 sites in 2 countries.
Trial summary
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Semaglutide J and Semaglutide C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Mar 2023to 29 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 23.0 and 34.9 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
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
- 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 highly effective contraceptives, routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen within 14 days before screening
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs, as judged by the investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Altasciences Clinical LA, Inc.
Cypress, California, 90630
Altasciences Clinical Kansas, Inc.
Kansas City, Kansas, 66212
About this study
Official title: A Randomised Study to Investigate Steady State Semaglutide Exposure of a New Formulation of Oral Semaglutide in Healthy Participants
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. The main aim of this study is to investigate semaglutide of 4 different doses in a new tablet by determining the amount of semaglutide in the blood and compare the concentration in the blood for the new tablet with the tablet currently investigated in a phase 3b study (current version). For this purpose, the amount of semaglutide in the blood will be measured after multiple doses of semaglutide, at different doses. Which doses participant will get will be decided by chance. The study will have 4 groups (A-D) and will include up to 260 participants. The doses participant get depends on the group they are (enrolled) in. All four groups will be receiving the investigational medicine for 15 weeks in total. Group A will start testing the dose level 1 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C for 5 weeks and then testing the dose level 3 (new tablet) for 5 weeks. Group B will start receiving the current tablet semaglutide C for 5 weeks and then testing the dose level 2 (new tablet) in 5 weeks and dose level 4 (new tablet) in 5 weeks. Group C will start testing the dose level 1 (new tablet) and dose level 3 (new tablet) for 5 weeks each and then receiving the current tablet of semaglutide C (2x dose) for 5 weeks. Group D will start testing the dose level 2 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C (2x dose) for 5 weeks and then testing the dose level 4 (new tablet) for 5 weeks. Participants will be receiving doses of semaglutide for 6 weeks before being assigned to one of the 4 groups (A-D) to reduce the risk of side effects. Participants cannot choose which group they want to be in, and they can only participate in one group in this study. Participant will get one tablet to be taken by mouth each day for approximately 21 weeks. The tablet should be taken in the morning together with no more than half a glass of water (120 milliliter [mL]), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing, participant must begin breakfast no earlier than 30 minutes and no later than 35 minutes after having taken tablet. The study will last for about 30 weeks in total for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (6 weeks), an investigational treatment period (15 weeks) and a follow-up period (5 weeks after last dose). The planned duration a participant can receive trial product is 21 weeks. Participant should not take any prescription or non-prescription medicines (including herbal products) within 14 days prior to the screening visit (visit 1) and until the follow-up visit, except for birth control, routine vitamins, medicines applied on the skin, and occasional use of acetaminophen or ibuprofen (a mild pain killer). No oral medication (medicine taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Healthy Participants
- Being tested
- Semaglutide J, Semaglutide C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide JDrug
Participants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D.
Semaglutide CDrug
Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Semaglutide J-Semaglutide C-Semaglutide J | Experimental | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide C once daily for next 4 weeks and thereafter semaglutide J at dose level 3 once daily for next 4 weeks. Receives: Drug: Semaglutide J; Drug: Semaglutide C |
| Sequence B: Semaglutide C-Semaglutide J-Semaglutide J | Experimental | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide C once daily for 4 weeks followed by semaglutide J at dose level 2 once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. Receives: Drug: Semaglutide J; Drug: Semaglutide C |
| Sequence C: Semglutide J-Semaglutide J-Semaglutide C | Experimental | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide J at dose level 3 once daily for next 4 weeks and thereafter semaglutide C (2x dose) once daily for next 4 weeks. Receives: Drug: Semaglutide J; Drug: Semaglutide C |
| Sequence D: Semaglutide J-Semaglutide C-Semaglutide J | Experimental | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 2 once daily for 4 weeks followed by semaglutide C (2x dose) once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. Receives: Drug: Semaglutide J; Drug: Semaglutide C |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From 0 to 24 hours after dosing on days 77, 112 and 147
Secondary outcomes (2)
Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state
Measured in nanomoles per liter (nmol/L).
Measured: From 0 to 24 hours after dosing on days 77, 112 and 147
tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state
Measured in hours (h).
Measured: From 0 to 24 hours after dosing on days 77, 112 and 147
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start16 Mar 2023
- Primary completion23 Feb 2024
- Study completion29 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 264 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
- NCT05784402
- Sponsor's protocol ID
- NN9924-4891
- Other IDs
- U1111-1279-6289
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study to Investigate Steady State Semaglutide Exposure of a New Formulation of Oral Semaglutide in Healthy Participants
- ClinicalTrials.gov ID
- NCT05784402
- Acronym / sponsor ID
- NN9924-4891
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 24 Mar 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 investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. The main aim of this study is to investigate semaglutide of 4 different doses in a new tablet by determining the amount of semaglutide in the blood and compare the concentration in the blood for the new tablet with the tablet currently investigated in a phase 3b study (current version). For this purpose, the amount of semaglutide in the blood will be measured after multiple doses of semaglutide, at different doses. Which doses participant will get will be decided by chance. The study will have 4 groups (A-D) and will include up to 260 participants. The doses participant get depends on the group they are (enrolled) in. All four groups will be receiving the investigational medicine for 15 weeks in total. Group A will start testing the dose level 1 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C for 5 weeks and then testing the dose level 3 (new tablet) for 5 weeks. Group B will start receiving the current tablet semaglutide C for 5 weeks and then testing the dose level 2 (new tablet) in 5 weeks and dose level 4 (new tablet) in 5 weeks. Group C will start testing the dose level 1 (new tablet) and dose level 3 (new tablet) for 5 weeks each and then receiving the current tablet of semaglutide C (2x dose) for 5 weeks. Group D will start testing the dose level 2 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C (2x dose) for 5 weeks and then testing the dose level 4 (new tablet) for 5 weeks. Participants will be receiving doses of semaglutide for 6 weeks before being assigned to one of the 4 groups (A-D) to reduce the risk of side effects. Participants cannot choose which group they want to be in, and they can only participate in one group in this study. Participant will get one tablet to be taken by mouth each day for approximately 21 weeks. The tablet should be taken in the morning together with no more than half a glass of water (120 milliliter [mL]), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing, participant must begin breakfast no earlier than 30 minutes and no later than 35 minutes after having taken tablet. The study will last for about 30 weeks in total for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (6 weeks), an investigational treatment period (15 weeks) and a follow-up period (5 weeks after last dose). The planned duration a participant can receive trial product is 21 weeks. Participant should not take any prescription or non-prescription medicines (including herbal products) within 14 days prior to the screening visit (visit 1) and until the follow-up visit, except for birth control, routine vitamins, medicines applied on the skin, and occasional use of acetaminophen or ibuprofen (a mild pain killer). No oral medication (medicine taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Semaglutide J-Semaglutide C-Semaglutide J | Experimental | Drug: Semaglutide J, Drug: Semaglutide CAfter 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide C once daily for next 4 weeks and thereafter semaglutide J at dose level 3 once daily for next 4 weeks. |
| Sequence B: Semaglutide C-Semaglutide J-Semaglutide J | Experimental | Drug: Semaglutide J, Drug: Semaglutide CAfter 6 weeks of run-in dose escalation period participants will orally receive semaglutide C once daily for 4 weeks followed by semaglutide J at dose level 2 once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. |
| Sequence C: Semglutide J-Semaglutide J-Semaglutide C | Experimental | Drug: Semaglutide J, Drug: Semaglutide CAfter 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide J at dose level 3 once daily for next 4 weeks and thereafter semaglutide C (2x dose) once daily for next 4 weeks. |
| Sequence D: Semaglutide J-Semaglutide C-Semaglutide J | Experimental | Drug: Semaglutide J, Drug: Semaglutide CAfter 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 2 once daily for 4 weeks followed by semaglutide C (2x dose) once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 23.0 and 34.9 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 (4 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
- 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 highly effective contraceptives, routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen within 14 days before screening
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs, as judged by the investigator
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 JParticipants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D. | Drug | Sequence A: Semaglutide J-Semaglutide C-Semaglutide J, Sequence B: Semaglutide C-Semaglutide J-Semaglutide J, Sequence C: Semglutide J-Semaglutide J-Semaglutide C, Sequence D: Semaglutide J-Semaglutide C-Semaglutide J |
| Semaglutide CParticipants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D. | Drug | Sequence A: Semaglutide J-Semaglutide C-Semaglutide J, Sequence B: Semaglutide C-Semaglutide J-Semaglutide J, Sequence C: Semglutide J-Semaglutide J-Semaglutide C, Sequence D: Semaglutide J-Semaglutide C-Semaglutide J |
Primary outcome
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
Time frame: From 0 to 24 hours after dosing on days 77, 112 and 147
Measured in hours*nanomoles per liter (h*nmol/L).
2 secondary outcomes
Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state
Time frame: From 0 to 24 hours after dosing on days 77, 112 and 147
tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state
Time frame: From 0 to 24 hours after dosing on days 77, 112 and 147
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 2 Dec 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide J and Semaglutide C in people with Healthy Participants, run by Novo Nordisk A/S at 3 sites in 2 countries.
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 4 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (time frame: From 0 to 24 hours after dosing on days 77, 112 and 147). 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 2 Dec 2025.