Not yet recruitingPHASE3INTERVENTIONAL

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

This research study is looking into a new medicine called Elecoglipron for adults who have Type 2 Diabetes. The main goal is to find out how well it works and if it's safe, compared to a medicine already in use called Semaglutide. Participants in this study will have Type 2 Diabetes that isn't currently well-managed with their usual care, and they will also have an increased risk of heart and blood vessel problems. We want to see if Elecoglipron can help manage blood sugar levels and improve health for these individuals. This is a Phase 3 study, meaning it's a late-stage trial before a medicine might become widely available.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,200

Start

06 Jul 2026

Estimated completion

23 May 2028

Type 2 Diabetes Mellitus

What is this study about?

This study is designed to explore a new potential medication, Elecoglipron, for people living with Type 2 Diabetes. We're comparing it directly with Semaglutide, which is a treatment that doctors already use to help manage Type 2 Diabetes. The main aim is to understand if Elecoglipron is a good option for people whose diabetes isn't fully under control, even when they're taking other diabetes medicines or trying to manage it through lifestyle. We also want to see if it's suitable for those who are at a higher risk of heart-related issues.

Type 2 Diabetes is a common condition where the body doesn't produce enough insulin or doesn't use insulin properly, leading to high blood sugar levels. Over time, high blood sugar can lead to serious health problems, including heart disease. Finding new, effective treatments is really important to help people manage their diabetes and stay healthier.

This study is a 'Phase 3' trial. This means it's one of the final stages of testing a new medicine before it can be considered for approval. At this stage, a larger number of people are involved to get a very clear picture of how safe and effective the medicine is.

Key takeaways

The study is comparing a new Type 2 Diabetes medicine (Elecoglipron) with an existing one (Semaglutide).
It's for adults with Type 2 Diabetes whose condition isn't well-controlled and who have a higher risk of heart problems.
The main goals are to check how well the new medicine works and if it's safe.
Participation involves regular clinic visits, taking study medication, and health checks.
You won't know if you're receiving the new or existing medicine.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be an adult (18 or older) who has been diagnosed with Type 2 Diabetes for at least three months. Your diabetes shouldn't be fully controlled with your current treatment or lifestyle changes, and your average blood sugar level (HbA1c) should be between 7% and 10.5%. You also need to have a higher risk of heart problems, for example, if you've already had certain heart conditions or have several risk factors for them. Your body mass index (BMI) should be 23 or higher, and your weight should have been stable for the last three months.

There are also some reasons why you wouldn't be able to join. For instance, if you have Type 1 Diabetes, other specific forms of diabetes, or a history of very low blood sugar episodes. If you have severe heart failure, certain stomach problems, or a history of pancreas inflammation, you also wouldn't be eligible. The study also excludes people with a personal or family history of certain thyroid cancers.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or over?
Do you have Type 2 Diabetes that isn't fully controlled?
Is your average blood sugar (HbA1c) between 7% and 10.5%?
Do you have an increased risk of heart problems?
Has your weight been stable for the last three months?
Do you NOT have Type 1 Diabetes or severe heart failure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, Elecoglipron, or the existing medicine, Semaglutide. You won't know which one you're receiving, nor will your study doctor, as this helps ensure the study results are fair. You'll have regular visits to the study clinic where the research team will check your health, measure your blood sugar, and see how you're responding to the treatment. This will involve blood tests, physical examinations, and discussions about how you're feeling. The study will last for a specific period, and during this time, you'll be asked to take your study medication as instructed and attend all scheduled appointments. The study team will explain all the details, including the number of visits and the total length of your participation, before you make any decisions.

Potential risks and benefits

Participating in a clinical trial might offer some potential benefits, such as gaining access to a new medicine before it's widely available and receiving close medical attention from a team of healthcare professionals. However, there are also potential risks, as with any medication, including side effects or that the treatment may not work for you. All possible risks will be fully explained to you before you decide to take part. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (158)

Research Site
Verified postcode
Birmingham, United States
Research Site
Verified postcode
Mesa, United States
Research Site
Verified postcode
Phoenix, United States
Research Site
Verified postcode
Tempe, United States
Research Site
Verified postcode
Encinitas, United States
Research Site
Verified postcode
Garden Grove, United States
Research Site
Verified postcode
Lincoln, United States
Research Site
Verified postcode
Loma Linda, United States
Research Site
Verified postcode
Pomona, United States
Research Site
Verified postcode
Crystal River, United States
Research Site
Verified postcode
Hollywood, United States
Research Site
Verified postcode
Jacksonville, United States

Common questions

What is Type 2 Diabetes?

Type 2 Diabetes is a condition where your body doesn't make enough insulin or doesn't use insulin properly, leading to high blood sugar levels. It's often managed with lifestyle changes and medication.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past two to three months. It's a key measure for how well your diabetes is controlled.

What does 'increased cardiovascular risk' mean?

This means you have a higher chance of developing heart and blood vessel problems, which might be due to existing conditions like heart disease, or risk factors such as high blood pressure or cholesterol.

Will I know if I'm getting the new medicine or the existing one?

No, in this type of study, neither you nor your study doctor will know which treatment you are receiving. This is called 'blinded' and helps ensure the study results are unbiased.

How long will the study last?

The full duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you by the study team before you join.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.