Not yet recruitingPHASE3INTERVENTIONAL

A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.

This research study is investigating a new medication called elecoglipron. It's designed for adults living with chronic kidney disease (CKD), which is a long-term condition where the kidneys don't work as well as they should. The main goal is to see if elecoglipron can lead to better health outcomes compared to a 'dummy' pill, known as a placebo. All participants will continue to take their current standard kidney treatments, including specific medications like dapagliflozin, which are already recommended for CKD. This is a 'Phase 3' study, meaning it's a large and important step before a new medicine might become widely available. Doctors and researchers want to find out if this new medicine is both safe and effective for people with kidney disease, including those who also have type 2 diabetes.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

7,000

Start

28 Aug 2026

Estimated completion

04 Oct 2030

Chronic Kidney Disease

What is this study about?

This study is all about understanding a new potential medicine called elecoglipron. It's for adults who have chronic kidney disease, often shortened to CKD. CKD means your kidneys aren't working as well as they should over a long period. Researchers want to see if elecoglipron can help people with this condition and lead to better health.

The study will compare elecoglipron to a 'placebo', which is a dummy pill that looks exactly like the real medicine but contains no active drug. This is a common and important way to find out if the new medicine is truly making a difference. All participants in the study will also continue taking their usual kidney disease treatments, including specific medicines like dapagliflozin, which are known to help with CKD.

This is a 'Phase 3' study, which is a big step in testing new medicines. It means many people will take part in different places, and neither the patients nor their doctors will know whether they are receiving elecoglipron or the placebo. This helps ensure the results are fair and accurate. The aim is to gather strong evidence to see if elecoglipron is safe and effective for people with chronic kidney disease, whether they also have type 2 diabetes or not.

Key takeaways

This study is testing a new medicine, elecoglipron, for chronic kidney disease.
It aims to see if elecoglipron is better than a dummy pill (placebo) when added to existing treatments.
Participants will continue to take their current kidney medications, like dapagliflozin.
The study is a large 'Phase 3' trial, which is an important step in developing new medicines.
Joining means regular health checks, blood tests, and taking either the study medicine or a placebo.

Who may be eligible?

To join this study, you need to be an adult with kidney disease that has been confirmed by a doctor. Your kidney tests should show certain levels of protein in your urine (UACR) and how well your kidneys are filtering (eGFR), all within specific ranges that the study team will check.

You also need to have been taking a stable dose of certain blood pressure medicines, like ACE inhibitors or ARBs, for at least four weeks before starting the study. These are common treatments for kidney disease and heart conditions.

There are also some reasons you wouldn't be able to join. For example, if you have a very low body weight, or if you have type 1 diabetes. You also can't participate if your blood sugar levels (HbA1c) are too high, or if you've had certain serious heart problems or strokes recently. People with a history of certain stomach or bowel problems, or a specific type of thyroid cancer in their family, would also not be able to take part.

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 with diagnosed chronic kidney disease?
Do you have certain levels of protein in your urine and kidney function that the study team will check?
Have you been on a stable dose of certain blood pressure medicines (like ACE inhibitors or ARBs) for at least four weeks?
Do you *not* have type 1 diabetes?
Have you *not* had a recent stroke, major heart procedure, or severe low blood sugar episodes?
Do you *not* have a history of specific stomach problems or certain cancers in your close family?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the new medicine (elecoglipron) or a dummy pill (placebo). You won't know which one you're taking, and neither will your study doctor. You'll continue to take your regular kidney disease medications, such as dapagliflozin, as prescribed.

Throughout the study, you'll have regular visits to the clinic. These visits will involve health checks, blood and urine tests, and discussions about how you're feeling and any side effects you might experience. These assessments help the study team monitor your health and see how the study medicine is affecting you. You'll need to follow specific instructions about taking your study medicine and attending all your scheduled appointments. The total duration of your participation in the study, including all follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical monitoring and access to a new treatment that isn't yet widely available. However, there's no guarantee the new medicine will help you, and you might receive the dummy pill. Like all medicines, elecoglipron could cause side effects, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (426)

Research Site
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Sheffield, United States
Research Site
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Surprise, United States
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Chula Vista, United States
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Waterbury, United States
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Chicago, United States
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Topeka, United States
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Beltsville, United States
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Boston, United States
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Troy, United States
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Edina, United States
Research Site
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Saint Paul, United States
Research Site
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Eatontown, United States

Common questions

What is chronic kidney disease (CKD)?

CKD means your kidneys are damaged and can't filter blood as well as they should. It's a long-term condition that can get worse over time.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but doesn't contain any active drug. It helps researchers fairly test if the new medicine truly works.

What does 'Phase 3' mean for a study?

Phase 3 means it's a large study, involving many people, designed to confirm if a new medicine is safe and effective before it can be approved for general use.

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

No, both you and your study doctor will not know if you're taking the new medicine or the placebo. This is to ensure the study results are fair and unbiased.

Can I stop participating in the study if I change my mind?

Yes, you are completely free to leave the study at any time, for any reason. Your decision will not affect your regular medical care.

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.