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NCT Number: NCT07753993

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

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
  • On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.

Exclusion criteria

  • BMI <23 kg/m² at screening
  • History of type 1 diabetes mellitus
  • HbA1c ≥10% (86 mmol/mol) at screening
  • Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
  • Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness
  • Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
  • Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
  • History of acute or chronic pancreatitis
  • History/family history (first degree) of medullary thyroid cancer or MEN2

Treatment and study plan

Elecoglipron

Drug

Elicoglipron tablet

Placebo

Drug

Placebo tablet

Primary outcomes

  1. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • ≥ 50% sustained decline in eGFR
    • ESKD defined as:

    Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant

    • All-cause mortality

Secondary outcomes

  1. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • ≥ 50% sustained decline in eGFR
    • ESKD defined as:

    Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant

    • CV and renal death

  2. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • All-cause mortality
    • MI
    • Stroke

  3. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • CV and renal death
    • MI
    • Stroke

  4. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to death from any cause

  5. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to death from CV cause

  6. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the pure renal composite of ≥ 50% sustained decline in eGFR, ESKD, or renal death

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • ≥ 50% sustained decline in eGFR
    • ESKD defined as:

    Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant

    • Renal death

  7. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to the first occurrence of any component of this composite:

    • CV death
    • HF hospitalizations (hHF)

  8. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite endpoint of CV death, MI, stroke, or HF hospitalizations

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to first occurrence of any component of this composite:

    • CV death
    • MI
    • Stroke
    • HF hospitalizations (hHF)

  9. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization

    Time frame: Event-driven, trial is estimated to be up to 4.5 years

    Time to hospitalization for any cause

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: Elevate-CKD

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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