Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
In this study a known investigational medicinal product called semaglutide will be tested in
 four different tablet versions. In addition to semaglutide, the different tablet versions C,
 D, E and F contain different helping agents in different amounts. All tablet versions have a
 helping agent called SNAC. All tablet versions are tested for the treatment of type 2
 diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and
 currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The
 main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher
 dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the
 amount of semaglutide in the blood to be higher than what has been tested before. Further
 aims of this study are to find an optimal version for the semaglutide tablets, and to examine
 the safety and tolerability of the different tablet versions. For this purpose, the amount of
 semaglutide in the blood will be measured after taking different semaglutide tablets, in
 different doses. The version of the tablet participants will receive (i.e. the treatment arm
 participants will be assigned to) is decided by chance.

 In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each
 period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks
 for each period (participants may get 2 tablets per day in treatment period 5). This means
 that treatment will take 16 weeks in total. The tablets should be taken in the morning
 together with no more than half a glass of water (120 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 participants must wait 30-35 minutes before they eat or drink. At home,
 participants must take their breakfast 30-45 minutes after dosing.

 No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30
 minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each
 participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks)
 and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic
 visits with the study doctor. Some of the visits include overnight stays. Participants will
 have blood tests at every visit. Participants must be healthy and have a body mass index
 (BMI) between 21.0 and 29.9 kg/m^2 For women: Women cannot take part in this study if they
 are pregnant, breast-feeding or plan to become pregnant during the study period.
Inclusion Criteria:

 -  Male or female, aged 18-64 years (both inclusive) at the time of signing informed
 consent.

 -  Body mass index between 21.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).

 -  Considered eligible 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:1) Smoking more than
 5 cigarettes or the equivalent per day.2) Not willing to refrain from smoking and use
 of nicotine substitute products during the inpatient periods.

 -  Presence of clinically significant gastrointestinal disorders or symptoms of
 gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as
 judged by the investigator.

 -  History (as declared by participant) of major surgical procedures involving the
 stomach potentially affecting absorption of trial products (e.g. subtotal and total
 gastrectomy, sleeve gastrectomy, gastric bypass surgery).

 -  Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or
 medullary thyroid carcinoma (as declared by participant).

 -  Presence or history (as declared by participant) of pancreatitis (acute or chronic).