Status:
COMPLETED
Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a ho...
Eligibility Criteria
Inclusion
- Male or female.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.
- Additional for healthy Japanese participants:
- First generation Japanese (Japanese born participants).
Exclusion
- HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening.
- Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
- Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) +10%
- Aspartate aminotransferase (AST) \> UNL+20%
- Total bilirubin \> UNL+20%
- Creatinine \> UNL+10%
- International normalised ratio (INR) \> UNL
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06069895
Start Date
October 4 2023
End Date
April 23 2025
Last Update
June 18 2025
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460