Not yet recruitingPHASE3INTERVENTIONAL

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

This research study is looking into a new medicine called Elecoglipron. It's for adults in the UK who have type 2 diabetes and also some kidney issues. The main goal is to find out if Elecoglipron is safe and helps manage their condition better than a dummy pill (placebo). Participants will already be taking, or start taking, a common diabetes medicine called dapagliflozin, along with other usual treatments. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might become widely available. It helps doctors understand if Elecoglipron could be a good new option to help people with type 2 diabetes and kidney problems.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

900

Start

06 Jul 2026

Estimated completion

13 Jul 2028

Type 2 Diabetes Mellitus Type 2 Diabetes With Chronic Kidney Disease

What is this study about?

This study is particularly for adults who have type 2 diabetes and are also experiencing some kidney problems. We want to see if a new medicine, Elecoglipron, can help these individuals. It's compared against a 'placebo', which looks identical but contains no active medicine. This comparison helps us understand the true effects of Elecoglipron.

Participants in this study will already be taking, or will start taking, a medicine called dapagliflozin. This is a common treatment for both type 2 diabetes and kidney disease. The study aims to find out if adding Elecoglipron to this existing treatment routine can further improve health, manage diabetes better, and is safe for people with kidney issues.

This is a 'Phase 3' study, which means it’s a big step in the development of new medicines. Results from studies like this help medical experts decide if a new treatment is effective and safe enough to be made available more widely. Your involvement could help improve future treatments for countless people with type 2 diabetes and kidney disease.

Key takeaways

New medicine called Elecoglipron tested for type 2 diabetes and kidney issues.
Compares Elecoglipron to a dummy pill (placebo).
Suitable if you're taking dapagliflozin and other diabetes medicines.
Close health monitoring throughout the study.
Could help improve future treatments for diabetes and kidney disease.
You can leave the study at any time.

Who may be eligible?

The study is looking for adults aged 18 or over who have had type 2 diabetes for at least three months. You also need to have some kidney problems and be taking, or able to start taking, a medicine called dapagliflozin, along with other diabetes medicines.

Your blood sugar levels (measured by an HbA1c test) need to be within a certain range at the start of the study, and your body weight (BMI) should be 23 or above. You also need to have had a stable weight for the past three months.

However, some people won't be able to join. This includes if you have type 1 diabetes, other rare forms of diabetes, or a history of severe blood sugar lows. Also, if you have certain heart conditions, severe digestive problems, or a history of pancreatitis, you might not be suitable. The doctors will carefully check all these details to make sure the study is right and safe for you.

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 an adult aged 18 or older?
Have you had type 2 diabetes for at least 3 months?
Do you have some kidney problems (impaired renal function)?
Are you currently taking, or able to take, dapagliflozin and other diabetes medicines?
Is your BMI 23 or higher?
Have you had a stable weight for the past 3 months?

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 a dummy pill (placebo). You won't know which one you're receiving, and neither will your study doctor. You'll continue to take your other regular diabetes medicines, including dapagliflozin.

Throughout the study, you'll have regular visits to the clinic for health checks, blood tests, and to discuss how you're feeling. These visits help the doctors monitor your health, blood sugar levels, and kidney function, as well as track any side effects. You'll be given instructions on how to take the study medicine and when to have your follow-up appointments. The total length of your participation in the study will be explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer monitoring of your health and access to a new medicine that could help your diabetes and kidney function. However, the new medicine might not help you, or you could experience side effects. It's also possible that the dummy pill has no benefits for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (162)

Research Site
Verified postcode
Peoria, United States
Research Site
Verified postcode
Surprise, United States
Research Site
Verified postcode
Concord, United States
Research Site
Verified postcode
Lincoln, United States
Research Site
Verified postcode
Victorville, United States
Research Site
Verified postcode
Fleming Island, United States
Research Site
Verified postcode
Hialeah, United States
Research Site
Verified postcode
Lauderdale Lakes, United States
Research Site
Verified postcode
Leesburg, United States
Research Site
Verified postcode
Ocoee, United States
Research Site
Verified postcode
Orlando, United States
Research Site
Verified postcode
Braintree, United States

Common questions

What is Elecoglipron?

Elecoglipron is a new medicine being tested to see if it can help people with type 2 diabetes and kidney problems.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps us see if the new medicine really works.

Will I still take my regular diabetes medicines?

Yes, you will continue your usual diabetes medicines, including dapagliflozin, if you are already taking it or start it as part of your normal care.

What does 'impaired renal function' mean?

It means your kidneys are not working as well as they should, which is a common problem for people with type 2 diabetes.

How long will the study last?

The study team will tell you the exact length of your participation during the consent process.

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.