A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
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.
Inclusion Criteria:

 -  Male or female, aged 18-64 years (both inclusive) at the 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.

 Exclusion Criteria:

 -  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).