New Combination Therapy Could Help Lower Glucose Levels
Learn more about this clinical trial by Novo Nordisk, that is testing whether a new medication, when combined with semaglutide (also known as Wegovy), can help people with type 2 diabetes lower their glucose levels and lose weight.
Clinical Trials Identifier: NCT05144984
Trial Name: A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Diabetes Type: Adults with type 2 diabetes
Trial Sponsor: Novo Nordisk
What is the trial testing?
This study will enroll 495 participants with type 2 diabetes to evaluate their glucose levels while taking a new drug in combination with semaglutide. The new drug does not have a name yet and is currently identified as NNC0480-0389. Participants will be randomly assigned to different groups that will receive either a combination of semaglutide and the new drug, or semaglutide with a placebo. If participants are given the experimental NNC0480-0389 drug, they will receive one of four different dose levels. Treatment will be given by injection, regardless of the different dose levels.
Researchers will measure participants’ average change in A1C from baseline to end of trial. They will also measure changes in fasting glucose levels, body weight, cholesterol, and blood pressure. Over the course of the study, participants will have 20 in-clinic visits, where researchers will take blood samples to measure each outcome.
Why is this trial new and important?
GLP-1 receptor agonists like semaglutide (Wegovy, Ozempic, and Rybelsus) have been shown to have several benefits for people with type 2 diabetes. These include helping people lower their glucose, lose weight, and protect against complications such as heart disease and kidney disease. Multiple GLP-1 drugs have received approval in recent years, helping millions who are living with type 2 diabetes and struggling with weight management.
Tirzepatide, a drug that has received a lot of publicity due to very encouraging trial results, is a slight twist on a GLP-1, known as a “dual GIP and GLP-1 receptor agonist.” While Tirzepatide was the first drug of its kind, this trial is testing a new “dual agonist” therapy consisting of semaglutide (the GLP-1 component) and the new drug, NNC0480-0389 (the GIP component). This trial is currently in phase two and will help researchers determine the most effective doses of each component before moving into the next phase of trials.
Trial Length: 41 weeks
Trial Locations: This is a multicenter, worldwide study with 85 locations across the United States, Denmark, Bulgaria, Greece, Hungary, Serbia, Poland, and Japan. You can see a list of all participating locations here.
Are you interested?
You may be eligible to participate in this trial if:
You are an adult with type 2 diabetes, diagnosed at least 180 days before screening for the trial
Your current A1C is between 7.0% and 10.0%
You have a BMI between 25 and 40 kg/m2
You do NOT have uncontrolled diabetes-related retinopathy
You can see a full list of inclusion/exclusion criteria here.
For more information: To learn more, you can contact the Novo Nordisk study team at email@example.com or call (+1) 866-867-7178.