Healthy Volunteers Type 2 DiabetesPhase 1NCT04513704
A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
A Phase 1 study testing Oral Semaglutide in people with Healthy Volunteers Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
The goal of this trial is to find out whether taking semaglutide tablets at different times before and after eating has a similar effect compared to the recommended dosing time. Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral… 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?
- Oral Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2020to 26 May 2021
- 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 time of signing informed consent.
- Body mass index (BMI) between 20.0 and 29.9 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 haemoglobin (HbA1c) greater than or equal to 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 during the in-house period.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by subject or reported in the medical records).
- Presence or history (as declared by subject or reported in the medical records) of pancreatitis (acute or chronic).
- History (as declared by subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules
The goal of this trial is to find out whether taking semaglutide tablets at different times before and after eating has a similar effect compared to the recommended dosing time. Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral medicine for at least 30 minutes after that. The trial will look at how different dosing times of semaglutide before and after eating a meal changes how much semaglutide participants get into their blood. Participants will get one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine (3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance under which dosing condition participants will receive the trial medicine: A 2 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial medicine, participants will fast for 4 hours and then receive a standardised meal. The meal should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with the study doctor. At one of the visits, participants will be admitted to the trial unit and have to stay for 12 consecutive days. At all visits participants will meet with trial staff and will have blood tests along with other clinical checks and tests. Participants will be asked about their health, medical history, and habits. Women only: Women cannot take part if pregnant, breast-feeding, or planning to become pregnant during the trial period.
- Conditions
- Healthy Volunteers Type 2 Diabetes
- Being tested
- Oral Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral SemaglutideDrug
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
| Study group | Role | What they receive |
|---|---|---|
| Oral Semaglutide A | Experimental | Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 2 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. Receives: Drug: Oral Semaglutide |
| Oral Semaglutide B | Experimental | Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 4 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. Receives: Drug: Oral Semaglutide |
| Oral Semaglutide C | Experimental | Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 6 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. Receives: Drug: Oral Semaglutide |
| Oral Semaglutide D | Experimental | Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-dose fasting time of 2 hours followed by a post-dose overnight fast. Receives: Drug: Oral Semaglutide |
| Oral Semaglutide E | Active comparator | Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days). Participants will be instructed to take the trial product in the morning after an overnight fast and wait 30 minutes before taking any food, water or other oral medication in accordance with the approved dosing schedule for oral semaglutide. Receives: Drug: Oral Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide plasma concentration - time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,day10)
nmol*h/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Secondary outcomes (2)
Maximum observed semaglutide plasma concentration after the 10th dosing (Cmax,0-24h,sema,day10)
nmol/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum observed semaglutide plasma concentration after the 10th dosing (tmax,0-24h,sema,day10)
hours (h)
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start28 Aug 2020
- Primary completion20 Apr 2021
- Study completion26 May 2021
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513704
- Sponsor's protocol ID
- NN9924-4556
- Other IDs
- U1111-1243-9641, 2019-004569-42, 2019
- Status last verified
- May 2023
- First submitted
- 12 Aug 2020
- Last updated
- 12 May 2023
- 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
van Hout M, Forte P, Jensen TB, Boschini C, Baekdal TA. Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects. Clin Pharmacokinet. 2023 Apr;62(4):635-644. doi: 10.1007/s40262-023-01223-9. Epub 2023 Mar 17.
PubMed 36932262
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules
- ClinicalTrials.gov ID
- NCT04513704
- Acronym / sponsor ID
- NN9924-4556
- Conditions
- Healthy Volunteers Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 14 Aug 2020 (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 goal of this trial is to find out whether taking semaglutide tablets at different times before and after eating has a similar effect compared to the recommended dosing time. Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral medicine for at least 30 minutes after that. The trial will look at how different dosing times of semaglutide before and after eating a meal changes how much semaglutide participants get into their blood. Participants will get one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine (3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance under which dosing condition participants will receive the trial medicine: A 2 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial medicine, participants will fast for 4 hours and then receive a standardised meal. The meal should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with the study doctor. At one of the visits, participants will be admitted to the trial unit and have to stay for 12 consecutive days. At all visits participants will meet with trial staff and will have blood tests along with other clinical checks and tests. Participants will be asked about their health, medical history, and habits. Women only: Women cannot take part if pregnant, breast-feeding, or planning to become pregnant during the trial period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Semaglutide A | Experimental | Drug: Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 2 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. |
| Oral Semaglutide B | Experimental | Drug: Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 4 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. |
| Oral Semaglutide C | Experimental | Drug: Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 6 hours of the pre-dose fast, followed by a 30 minutes post-dose fast. |
| Oral Semaglutide D | Experimental | Drug: Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-dose fasting time of 2 hours followed by a post-dose overnight fast. |
| Oral Semaglutide E | Active comparator | Drug: Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days). Participants will be instructed to take the trial product in the morning after an overnight fast and wait 30 minutes before taking any food, water or other oral medication in accordance with the approved dosing schedule for oral semaglutide. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-64 years (both inclusive) at time of signing informed consent.
- Body mass index (BMI) between 20.0 and 29.9 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)
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below:
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by subject or reported in the medical records).
- Presence or history (as declared by subject or reported in the medical records) of pancreatitis (acute or chronic).
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 |
|---|---|---|
| Oral SemaglutideParticipants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days). | Drug | Oral Semaglutide A, Oral Semaglutide B, Oral Semaglutide C, Oral Semaglutide D, Oral Semaglutide E |
Primary outcome
Area under the semaglutide plasma concentration - time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,day10)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
nmol*h/L
2 secondary outcomes
Maximum observed semaglutide plasma concentration after the 10th dosing (Cmax,0-24h,sema,day10)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum observed semaglutide plasma concentration after the 10th dosing (tmax,0-24h,sema,day10)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
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 12 May 2023.
- Derived from this study: PubMed 36932262van Hout M, Forte P, Jensen TB, Boschini C, Baekdal TA. Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects. Clin Pharmacokinet. 2023 Apr;62(4):635-644. doi: 10.1007/s40262-023-01223-9. Epub 2023 Mar 17.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Healthy Volunteers Type 2 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingPhase 2
A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
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 Reporting Anchor and Disclosure 1452 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 Oral Semaglutide in people with Healthy Volunteers Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 3 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 12 May 2023. 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 United Kingdom. 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?
Area under the semaglutide plasma concentration - time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,day10) (time frame: From 0 to 24 hours after the 10th dosing (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 NCT04513704, 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 12 May 2023.