CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 500 enrolled
Drug / intervention
NNC0480-0389 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05144984
NCT05144984Phase 2Completed

Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study

Novo Nordisk A/S·interventional·Posted Dec 6, 2021·Updated Apr 9, 2026

In Brief

A Phase 2 clinical trial evaluating NNC0480-0389, Semaglutide, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 500 participants across 129 sites in 9 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Denmark, Greece, Hungary, Japan, Poland, Russia, Serbia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 6, 2021
Enrollment StartNov 29, 2021
Primary CompletionFeb 13, 2023
Study CompletionMar 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.6 years ago

Interventions

NNC0480-0389drug

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

Semaglutidedrug

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.