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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
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
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Pinnacle Research Group LLC
Anniston, Alabama, United States
Synexus Clinical Research
Glendale, Arizona, United States
University of Arizona/Banner Health
Phoenix, Arizona, United States
American Clinical Trials
Buena Park, California, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Velocity Clinical Research San Diego
La Mesa, California, United States
Start Date
November 29, 2021
Primary Completion Date
February 13, 2023
Completion Date
March 23, 2023
Last Updated
November 26, 2025
500
ACTUAL participants
NNC0480-0389
DRUG
Semaglutide
DRUG
Placebo (NNC080-0389)
DRUG
Placebo (semaglutide)
DRUG
Lead Sponsor
Novo Nordisk A/S
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062