A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

NCT05144984 · Completed

Last updated 2026-05-28

This clinical trial is testing how well a combination of the medications semaglutide and NNC0480-0389 works in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 500 people

Who can join Ages 18–75 · all sexes

Timeline Started 2021-11 · est. completion 2023-03

Where 129 sites · Bulgaria, Denmark, Greece, Hungary, Japan, Poland, Russia, Serbia, United States

What this study is testing ClinicalTrials.gov NCT05144984 ↗

Description as written by the study sponsor.

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant

Treatments tested

NNC0480-0389 Drug

A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide Drug

A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Placebo (NNC080-0389) Drug

A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide) Drug

A weekly dose of placebo (semaglutide). The study will last for about 41weeks.

Main thing measured	Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05144984 ↗