NCT06069895

Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	NNC0113-6856	NNC0113-6856 will be administered as oral tablets.
DRUG	Placebo	NNC0113-6856 matching placebo will be administered as oral tablets.

Timeline

• Start date: 2023-10-04
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2023-10-06
• Last updated: 2025-06-18

Locations

1 site across 1 country: Germany