Status:
COMPLETED
A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers Type 2 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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.
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:
- 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).
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04513704
Start Date
August 28 2020
End Date
May 26 2021
Last Update
May 12 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ