Healthy VolunteersPhase 1NCT05227196
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
A Phase 1 study testing Semaglutide D Dose 1, Semaglutide D Dose 2 and Semaglutide D Dose 3 in people with Healthy Volunteers and Type 2 Diabetes, run by Novo Nordisk A/S at 3 sites in 2 countries.
Trial summary
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Type 2 Diabetes
- 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?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Feb 2022to 8 Aug 2023
- 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
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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
- HbA1c equal to or greater than 6.5 % (48 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.
- History(a) 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(a).
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
- As declared by the participant or reported in the medical records
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.
Overland Park, Kansas, 66212
About this study
Official title: A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.
The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.
The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
- Conditions
- Healthy Volunteers, Type 2 Diabetes
- Being tested
- Semaglutide D Dose 1, Semaglutide D Dose 2, Semaglutide D Dose 3, Semaglutide Dose 4, Semaglutide Dose 5
- Medical subject headings
- Diabetes Mellitus, Type 2
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 Dose 4Drug
Tablet given orally
Semaglutide Dose 5Drug
Tablet given orally
Semaglutide Dose 6Drug
Tablet given orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Sequence 1 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide D Dose 3; Drug: Semaglutide Dose 6 |
| Group 1 Sequence 2 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 3; Drug: Semaglutide Dose 4; Drug: Semaglutide Dose 5; Drug: Semaglutide Dose 6 |
| Group 2 Sequence 1 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide Dose 4; Drug: Semaglutide Dose 5 |
| Group 2 Sequence 2 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide Dose 4; Drug: Semaglutide Dose 5 |
| Group 3 Sequence 1 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 1; Drug: Semaglutide Dose 4 |
| Group 3 Sequence 2 | Experimental | Crossover arm Receives: Drug: Semaglutide D Dose 1; Drug: Semaglutide Dose 4 |
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 (SS)
h∙nmol/L
Measured: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
nmol/L
Measured: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Secondary outcomes (2)
tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state
h
Measured: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state
nmol/L
Measured: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start4 Feb 2022
- Primary completion28 Jun 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- 546 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
- NCT05227196
- Sponsor's protocol ID
- NN9924-4799
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2022
- Last updated
- 19 Sep 2024
- 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
Publications
Nielsen MS, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth TV, Patted UR, van Hout M. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Diabetes Ther. 2025 Feb;16(2):269-287. doi: 10.1007/s13300-024-01674-8. Epub 2024 Dec 21.
PubMed 39708086
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
- ClinicalTrials.gov ID
- NCT05227196
- Acronym / sponsor ID
- NN9924-4799
- Conditions
- Healthy Volunteers, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 7 Feb 2022 (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.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.
The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.
The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 Sequence 1 | Experimental | Drug: Semaglutide D Dose 1, Drug: Semaglutide D Dose 2, Drug: Semaglutide D Dose 3, Drug: Semaglutide Dose 6Crossover arm |
| Group 1 Sequence 2 | Experimental | Drug: Semaglutide D Dose 3, Drug: Semaglutide Dose 4, Drug: Semaglutide Dose 5, Drug: Semaglutide Dose 6Crossover arm |
| Group 2 Sequence 1 | Experimental | Drug: Semaglutide D Dose 1, Drug: Semaglutide D Dose 2, Drug: Semaglutide Dose 4, Drug: Semaglutide Dose 5Crossover arm |
| Group 2 Sequence 2 | Experimental | Drug: Semaglutide D Dose 1, Drug: Semaglutide D Dose 2, Drug: Semaglutide Dose 4, Drug: Semaglutide Dose 5Crossover arm |
| Group 3 Sequence 1 | Experimental | Drug: Semaglutide D Dose 1, Drug: Semaglutide Dose 4Crossover arm |
| Group 3 Sequence 2 | Experimental | Drug: Semaglutide D Dose 1, Drug: Semaglutide Dose 4Crossover arm |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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.
Key exclusion criteria (8 listed)
- HbA1c equal to or greater than 6.5 % (48 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.
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 D Dose 1Tablet given orally | Drug | Group 1 Sequence 1, Group 2 Sequence 1, Group 2 Sequence 2, Group 3 Sequence 1, Group 3 Sequence 2 |
| Semaglutide D Dose 2Tablet given orally | Drug | Group 1 Sequence 1, Group 2 Sequence 1, Group 2 Sequence 2 |
| Semaglutide D Dose 3Tablet given orally | Drug | Group 1 Sequence 1, Group 1 Sequence 2 |
| Semaglutide Dose 4Tablet given orally | Drug | Group 1 Sequence 2, Group 2 Sequence 1, Group 2 Sequence 2, Group 3 Sequence 1, Group 3 Sequence 2 |
| Semaglutide Dose 5Tablet given orally | Drug | Group 1 Sequence 2, Group 2 Sequence 1, Group 2 Sequence 2 |
| Semaglutide Dose 6Tablet given orally | Drug | Group 1 Sequence 1, Group 1 Sequence 2 |
Primary outcome
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
h∙nmol/L
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
nmol/L
2 secondary outcomes
tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
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 19 Sep 2024.
- Derived from this study: PubMed 39708086Nielsen MS, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth TV, Patted UR, van Hout M. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Diabetes Ther. 2025 Feb;16(2):269-287. doi: 10.1007/s13300-024-01674-8. Epub 2024 Dec 21.
- 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 D Dose 1, Semaglutide D Dose 2 and Semaglutide D Dose 3 in people with Healthy Volunteers and Type 2 Diabetes, 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 8 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 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 (SS) (time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.). The study lists 2 primary outcomes in all. 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 NCT05227196, 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.