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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT05144984

Run by

Novo Nordisk A/S

People needed

500

Starts

2021-11-29

Expected to finish

2023-03-23

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
• Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
• HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
• BMI greater than or equal to 25 and below 40 kg/m\^2

You may not qualify if…

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

Where it is running

• 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
• First Valley Med Grp Lancaster — Lancaster, California, United States
• Torrance Clin Res Inst, Inc. — Lomita, California, United States
• Velocity Clin Res Los Angeles — Los Angeles, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Artemis Insitute for Clin Res — Riverside, California, United States
• Artemis Institute for Clin Res — San Diego, California, United States
• Shahram Jacobs MD Inc. — Sherman Oaks, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Northeast Research Institute — Jacksonville, Florida, United States
• Reyes Clinical Research, Inc — Miami, Florida, United States
• South Broward Research LLC — Miramar, Florida, United States
• Clinical Trial Res Assoc,Inc — Plantation, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Headlands Research - Sarasota — Sarasota, Florida, United States
• Appalachian Clinical Res LLC — Adairsville, Georgia, United States
• Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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