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

NCT04878406 · Completed

Last updated 2026-05-28

This study is testing how the experimental medicine NNC0480-0389, when taken with semaglutide, affects the body of healthy Japanese men.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 24 people

Who can join Ages 20–55 · male only Healthy volunteers accepted.

Timeline Started 2021-05 · est. completion 2021-07

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT04878406 ↗

Description as written by the study sponsor.

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.

Treatments tested

NNC0480-0389 Drug

A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.
Placebo (NNC0480-0389) Drug

A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.
Semaglutide Drug

A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.
Placebo (Semaglutide) Drug

A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Main thing measured	Number of treatment emergent adverse events (TEAEs)
Sponsor	Novo Nordisk A/S
Conditions studied	Healthy Volunteers Type 2 Diabetes
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04878406 ↗