*Elevate-CKD

  • Research type

    Research Study

  • Full title

    A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

  • IRAS ID

    1013884

  • Contact name

    Diana Ionescu

  • Contact email

    UKRegulatoryAffairs@astrazeneca.com

  • Sponsor organisation

    AstraZeneca AB

  • Research summary

    This study is testing whether a daily oral medicine, elecoglipron, can better protect the kidneys and help people live longer compared with a placebo tablet. Adults with chronic kidney disease (CKD), with or without type 2 diabetes, will continue standard care, including dapagliflozin 10 mg, and be randomly assigned to elecoglipron or placebo once daily. The dose is gradually increased and, after the specific time point described in the CSP, is maintained at a stable level. The trial continues until a sufficient number of kidney or survival events occur to provide answers.
    Adults with CKD across a broad range of kidney function and albumin in the urine may be eligible. Participants must have a body mass index above 23 kg/m². Those with recent heart attacks or major heart procedures, active severe diabetic eye disease, active biliary disease, or recent use of certain glucose‑lowering drugs cannot join. People with a history of glomerulonephritis on stable, low dose immune therapy may be eligible.
    Participants will attend regular clinic visits for checkups, blood and urine tests, heart tracing (ECGs), and vital signs. They will also complete brief questionnaires about quality of life and physical function. An optional patient feedback survey and optional blood/urine and genetics samples may be offered. A small subgroup will have extra blood tests to measure elecoglipron levels.
    The main goal is to see whether elecoglipron lowers the chance of a sustained 50% drop in kidney function, kidney failure (very low function, long‑term dialysis, or transplant), or death from any cause. The study also tracks heart attacks, strokes, heart‑failure hospitalisations, blood pressure, body weight, blood sugar, new‑onset diabetes, cholesterol, and inflammation. Safety is closely monitored throughout. Common GLP‑1–type stomach symptoms are expected to be mostly mild and lessen over time. An independent committee reviews important medical events to ensure reliable, unbiased results

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    26/LO/0283

  • Date of REC Opinion

    5 May 2026

  • REC opinion

    Further Information Favourable Opinion