NCT04878406

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.

Conditions

• Healthy Volunteers Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	NNC0480-0389	A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.
DRUG	Placebo (NNC0480-0389)	A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.
DRUG	Semaglutide	A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.
DRUG	Placebo (Semaglutide)	A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Timeline

• Start date: 2021-05-18
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2021-05-07
• Last updated: 2023-05-17

Locations

1 site across 1 country: Japan