Status:
COMPLETED
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers (Diabetes Mellitus, Type 2)
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparabl...
Eligibility Criteria
Inclusion
- Male or female
- Aged 20-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive)
Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
- Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits).
- Positive alcohol test at screening.
- Abuse or intake of drugs, defined as any of the below:
- Known or suspected drug or chemical substance abuse within 1 year before screening
- Positive drug of abuse test at screening
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05232708
Start Date
January 19 2022
End Date
August 30 2022
Last Update
January 26 2024
Active Locations (1)
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1
Parexel CPRU, Level 7
Harrow, Middlesex, United Kingdom, HA1 3UJ