> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-outcomes-with-elecoglipron-compared-5b771346-5577-442a-87a0-1e62210b68b2 > Record changed: 2026-11-04 # A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. NCT07753993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Participants 7,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Start date 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) Number of sites 715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Acronym** Elevate-CKD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Short title** A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Dates **Completion date** 2030-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **First posted** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Registry last updated** 2026-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Primary completion date** 2030-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Start date** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Size and sites **Participants** 7,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Planned participants** 7,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Number of sites** 715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Identifiers **Registry ID** NCT07753993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **ClinicalTrials.gov ID** NCT07753993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Outcomes ### 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 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 ### 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 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## References ### Other registry identifiers (2) - 2025 - 2025-523994-41-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753993) ## Related records ### Drugs (1) - [Elecoglipron](https://trialight.com/data/asset/elecoglipron-8e9246dc-f27c-5602-b7aa-f57855d22924.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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