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

NCT07753993
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
7,000
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Lead sponsor
AstraZeneca
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Start date
2026-08-21
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Number of sites
715
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Summary
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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Acronym
Elevate-CKD
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Short title
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
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Official 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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-10-04
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First posted
2026-08-10
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Registry last updated
2026-09-09
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Primary completion date
2030-10-04
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Start date
2026-08-21
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Participants
7,000
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Participant count basis
Estimated
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Planned participants
7,000
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Protocol amendments
1
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Number of sites
715
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07753993
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ClinicalTrials.gov ID
NCT07753993
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Placebo controlled
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

    Timeframe: 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

  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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

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

    Time to hospitalization for any cause

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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
Sources for eligibility
clinicaltrials.gov

  • Research SiteHuntsville, United StatesNot yet recruiting
  • Research SiteMontgomery, United StatesNot yet recruiting
  • Research SiteSheffield, United StatesNot yet recruiting
  • Research SitePeoria, United StatesNot yet recruiting
  • Research SitePhoenix, United StatesNot yet recruiting
  • Research SiteSurprise, United StatesNot yet recruiting
  • Research SiteLittle Rock, United StatesWithdrawn
  • Research SiteChula Vista, United StatesNot yet recruiting
  • Research SiteConcord, United StatesNot yet recruiting
  • Research SiteDaly City, United StatesNot yet recruiting
  • Research SiteFremont, United StatesNot yet recruiting
  • Research SiteHuntington Beach, United StatesNot yet recruiting
  • Research SiteHuntington Park, United StatesNot yet recruiting
  • Research SiteLomita, United StatesNot yet recruiting
  • Research SiteNational City, United StatesNot yet recruiting
  • Research SiteNorthridge, United StatesNot yet recruiting
  • Research SiteNorthridge, United StatesNot yet recruiting
  • Research SiteRolling Hills Estates, United StatesWithdrawn
  • Research SiteSan Diego, United StatesNot yet recruiting
  • Research SiteSan Francisco, United StatesWithdrawn
  • Research SiteSan Mateo, United StatesNot yet recruiting
  • Research SiteTarzana, United StatesNot yet recruiting
  • Research SiteArvada, United StatesNot yet recruiting
  • Research SiteDenver, United StatesNot yet recruiting
  • Research SiteHartford, United StatesNot yet recruiting

And 690 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523994-41-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)