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Randomized Phase III trial of elecoglipron plus dapagliflozin on kidney outcomes and mortality in adults with chronic kidney disease

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults with Chronic kidney disease (CKD), a condition where the kidneys gradually lose their ability to filter waste. Participants may have a range of kidney function measured by eGFR, which estimates how well the kidneys filter blood, and may show protein in the urine. All participants will continue taking the standard medication dapagliflozin at a dose of 10 mg daily, while the experimental drug Elecoglipron (code name AZD5004) or a matching placebo will be given as an oral tablet.

The aim of the trial is to see whether adding the experimental drug reduces the chance of a large and lasting drop in kidney function, the development of end-stage kidney disease (very low kidney function requiring dialysis or transplant), or death from any cause. Participants will be randomly assigned to receive either the study drug or placebo, will take the assigned tablet each day, and will be monitored with regular clinic visits, blood tests, and urine checks over several years to record any health events.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and assessments

    After joining the study you will attend a baseline visit where basic health information is recorded, blood and urine samples are taken, and kidney function is measured.

    The visit also confirms that you will receive either elecoglipron or a matching placebo in addition to your regular dapagliflozin 10 mg tablet.

  2. Step 2

    Randomization and medication allocation

    The study team will assign you randomly to one of two groups: the elecoglipron group or the placebo group.

    You will receive a film‑coated tablet to be taken by mouth once each day. the exact dose of elecoglipron is not disclosed in the public information, but the tablet is taken daily for the whole study period.

  3. Step 3

    Start of daily treatment

    Each day you will swallow the assigned tablet with water, preferably at the same time each day.

    You will continue your background therapy with dapagliflozin 10 mg taken once daily as part of standard care.

  4. Step 4

    Regular follow‑up visits

    Every few months (typically every 12 weeks) you will return to the clinic for a follow‑up visit.

    During these visits blood and urine tests will be repeated to monitor kidney function, safety parameters, and any side effects.

    The study medication and the background dapagliflozin will be continued unchanged unless a safety concern arises.

  5. Step 5

    Ongoing monitoring throughout the study

    You will remain on the assigned tablet for the duration of the trial, which may extend for several years (the study is scheduled from 2026 to 2030).

    Any new health events, such as significant decline in kidney function, need for dialysis, or hospitalization, will be recorded as part of the study outcomes.

  6. Step 6

    Final study visit and discontinuation

    At the end of the study period you will attend a final visit where the same set of tests performed at baseline will be repeated.

    After the final assessments you will stop taking the study tablet and continue any other prescribed medications as directed by your regular health‑care provider.

Who can join the trial?

9 criteria

  • You must be at least 18 years old and legally able to give consent.
  • You must have chronic kidney disease (CKD) that fits one of these lab ranges:
    • Urine albumin‑to‑creatinine ratio (UACR) between 30 and 200 mg/g and estimated glomerular filtration rate (eGFR) between 20 and less than 45 mL/min/1.73 m², or
    • UACR greater than 200 mg/g and eGFR between 20 and less than 60 mL/min/1.73 m², or
    • UACR greater than 500 mg/g and eGFR between 60 and less than 90 mL/min/1.73 m².
    • You must be taking a stable, maximum‑tolerated daily dose of an ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 28 days before screening, unless you cannot tolerate these medicines.
    • You can be male or female assigned at birth, and any gender identity is accepted, but you must follow the study’s contraception rules if you could become pregnant or if you are a male partner.
    • You must be able to sign the informed consent form and agree to follow the study’s requirements.
    • The informed consent form must be signed and dated before any study procedures or sample collection are done.
    • If you choose to join the optional genetics part of the study, you must also sign the optional genomics consent form before any genetic samples are taken.

Who cannot join the trial?

10 criteria

  • Your body mass index (BMI) is less than 23 kg/m² at the screening visit, meaning you are considered underweight for this study.
  • You have a personal or first‑degree family history of medullary thyroid cancer (a rare thyroid tumor) or MEN2 (a genetic condition that raises the risk of certain cancers).
  • You have been diagnosed with type 1 diabetes mellitus, a condition where the body cannot produce insulin.
  • Your blood test shows HbA1c of 10% or higher (86 mmol/mol), indicating poorly controlled blood sugar over the past few months.
  • You are currently receiving, or are expected to receive, treatment for diabetic retinopathy (damage to the eye’s blood vessels) or macular edema (swelling in the central part of the retina).
  • You have experienced more than one episode of severe hypoglycemia (dangerously low blood sugar) in the past 180 days, or you do not recognize the symptoms of low blood sugar (hypoglycemia unawareness).
  • You have been diagnosed with nephrotic syndrome (a kidney condition causing large protein loss in urine) or active glomerulonephritis (inflammation of the kidney’s filtering units).
  • You have had an acute coronary syndrome event (such as a heart attack), undergone a major heart procedure, experienced a stroke, or had a transient ischemic attack (TIA) within the last three months.
  • You have a significant problem affecting the upper gastrointestinal (GI) tract (esophagus, stomach, or upper small intestine) or you regularly take medicines that change how the stomach moves food (gastric motility) or empties (gastric emptying).
  • You have a past history of pancreatitis, which is inflammation of the pancreas, either as a single episode (acute) or ongoing (chronic).
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Investigated drugs

Elecoglipron
Elecoglipron is an experimental oral tablet that is being studied to see if it can lower the chance of serious kidney problems and death in people with chronic kidney disease. In the trial, participants take this medication regularly, and researchers compare their kidney health and survival to those who receive a placebo. The goal is to find out whether Elecoglipron can slow down the loss of kidney function and improve overall outcomes. Forxiga (dapagliflozin)
Forxiga, whose active ingredient is dapagliflozin, is an approved oral medication that helps control blood sugar levels and has protective effects on the kidneys. In this study, all participants continue to take Forxiga as part of their usual care while the new drug, Elecoglipron, is tested. This background therapy allows researchers to see how Elecoglipron works in addition to standard treatment.

What is already known about the treatment

  • Elecoglipron

    Elecoglipron is taken as a film‑coated tablet taken by mouth. It is an investigational drug that is still being studied and has not been approved for general medical use. The trial is testing it to see if it can help adults with chronic kidney disease by slowing kidney damage and reducing the risk of death. It is described as an oral agent that may work by influencing kidney cells and blood flow, but its exact class and molecular target are still under research.

  • Dapagliflozin

    Dapagliflozin is provided as a 10 mg film‑coated tablet taken orally once daily. It is an approved medication widely used for type 2 diabetes and chronic kidney disease and is listed in medical literature as a standard treatment. The drug belongs to the SGLT2 inhibitor class and works by blocking a protein in the kidney that re‑absorbs glucose, causing more sugar to leave the body in urine and helping protect kidney function. It is commonly prescribed to lower blood sugar and reduce the progression of kidney disease.

Investigated diseases

Chronic kidney disease - Chronic kidney disease is a long‑term condition where the kidneys gradually lose their ability to filter waste from the blood. It often starts with small amounts of protein leaking into the urine and a slow drop in the measured filtration rate. Over time the filtration rate continues to fall, moving the disease through defined stages. As the kidneys become less efficient, waste and fluid can build up in the body. The condition may eventually require dialysis or a kidney transplant if it reaches the most advanced stage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523994-41-00Protocol codeD7265C00001Estimated enrolment6 920 patientsSponsorAstraZeneca AB

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