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Elevate-CKD

RecruitingPhase 3

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

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)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

715

Recruiting sites

14

Estimated enrollment

7,000

Study population

Chronic kidney disease

Eligibility highlights

•eGFR ≥20•UACR ≥30

Primary endpoint

•Effect of elecoglipron

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07753993
Org study IDD7265C00001
Secondary ID2025
Secondary ID2025-523994-41-00

Timeline

Milestones

Study first posted2026-08-10actual
Study start2026-08-21actual
Last update posted2026-09-09actual
Primary completion2030-10-04estimated
Study completion2030-10-04estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Chronic kidney disease

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
3
Renal / kidney
3
Heart failure
2
Other clinical outcomes
2

Cardiovascular outcomes

3 endpoints
Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Heart failure

2 endpoints
Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Renal / kidney

3 endpoints
Primary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.