Status:
COMPLETED
Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
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 con...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT04524832
Start Date
September 29 2020
End Date
February 25 2022
Last Update
October 10 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050