Chronic Kidney DiseasePhase 3Elevate-CKDNCT07753993
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
A Phase 3 study testing Elecoglipron in people with Chronic Kidney Disease, run by AstraZeneca at 715 sites in 37 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Elecoglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,000 participants
- Where
- 715 sitesin 37 countries
- Study dates
- 21 Aug 2026to 4 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
715 sites in 37 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
715 sites in 37 countries
United States120 sites, 111 recruiting
- Not yet recruiting
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Albany, New York, 12205
- Not yet recruiting
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Albuquerque, New Mexico, 87106
- Withdrawn
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Ames, Iowa, 50010
- Recruiting
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Arlington, Texas, 76015
- Not yet recruiting
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Arlington, Virginia, 22205
- Not yet recruiting
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Arvada, Colorado, 80002
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Austell, Georgia, 30106
- Not yet recruiting
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Beaver, Pennsylvania, 15009
- Not yet recruiting
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Beltsville, Maryland, 20705
- Not yet recruiting
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Boca Raton, Florida, 33487
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Boston, Massachusetts, 02115
- Not yet recruiting
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Boynton Beach, Florida, 33435
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Brookhaven, Mississippi, 39601
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Brooklyn, New York, 11220
- Not yet recruiting
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Buffalo, New York, 14215
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Burlington, Vermont, 05401
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Champaign, Illinois, 61820
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Chesterfield, Missouri, 63005
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Chicago, Illinois, 60611
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Chicago, Illinois, 60640
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Chula Vista, California, 91910
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Cincinnati, Ohio, 45212
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Columbus, Georgia, 31904
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Concord, California, 94520
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Cutler Bay, Florida, 33157
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Dallas, Texas, 75246
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Daly City, California, 94015
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Denver, Colorado, 80220
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Detroit, Michigan, 48207
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East Point, Georgia, 30344
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East Providence, Rhode Island, 02914
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Eatontown, New Jersey, 07724
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El Paso, Texas, 79902
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Exton, Pennsylvania, 19341
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Flint, Michigan, 48532
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Fort Lauderdale, Florida, 33316
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Fremont, California, 94538
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Greensboro, North Carolina, 27405
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Hartford, Connecticut, 06112
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Hollywood, Florida, 33024
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Houston, Texas, 77036
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Houston, Texas, 77040
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Houston, Texas, 77054
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Huntington Beach, California, 92647
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Huntington Park, California, 90255
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Huntsville, Alabama, 35801
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Indiana, Pennsylvania, 15701
- Not yet recruiting
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Jacksonville Beach, Florida, 32250
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Jensen Beach, Florida, 34957
- Not yet recruiting
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Jersey City, New Jersey, 07306
- Withdrawn
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Knoxville, Tennessee, 37912
- Not yet recruiting
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Las Vegas, Nevada, 89101
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Las Vegas, Nevada, 89107
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Las Vegas, Nevada, 89146
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Lauderdale Lakes, Florida, 33313
- Withdrawn
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Little Rock, Arkansas, 72205
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Lomita, California, 90717
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Longwood, Florida, 32750
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Lubbock, Texas, 79430
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Maumee, Ohio, 43537
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McKinney, Texas, 75071
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Media, Pennsylvania, 19063
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Melbourne, Florida, 32901
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Mesquite, Texas, 75149
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Miami, Florida, 33125
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Miami, Florida, 33135
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Middlebury, Connecticut, 06762
- Not yet recruiting
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Mineola, New York, 11501
- Recruiting
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Minneapolis, Minnesota, 55435
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Minneapolis, Minnesota, 55435
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Montgomery, Alabama, 36117
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Morehead City, North Carolina, 28557
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Morristown, Tennessee, 37813
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National City, California, 91950
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New Bedford, Massachusetts, 02740
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Norfolk, Virginia, 23502
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Northridge, California, 91324
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Northridge, California, 91325
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Ocoee, Florida, 34761
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Orlando, Florida, 32806
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Paris, Texas, 75462
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Pasadena, Texas, 77504
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Pensacola, Florida, 32503
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Peoria, Arizona, 85382
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85012
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Plymouth Meeting, Pennsylvania, 19462
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97202
- Not yet recruiting
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Providence, Rhode Island, 02903
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Rapid City, South Dakota, 57701
- Not yet recruiting
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Riverview, Florida, 33578
- Not yet recruiting
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Rockford, Illinois, 61107
- Suspended
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Rocky Mount, North Carolina, 27804
- Withdrawn
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Rolling Hills Estates, California, 90274
- Not yet recruiting
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Saginaw, Michigan, 48604
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Saint Joseph, Michigan, 49085
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San Antonio, Texas, 78212
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San Antonio, Texas, 78230
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San Antonio, Texas, 78251
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San Diego, California, 92111
- Withdrawn
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San Francisco, California, 94110
- Not yet recruiting
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San Mateo, California, 94403
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Seattle, Washington, 98122
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Sheffield, Alabama, 35660
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Shelby, North Carolina, 28150
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Shenandoah, Texas, 77384
- Recruiting
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South Salt Lake, Utah, 84115
- Not yet recruiting
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Southfield, Michigan, 48075
- Suspended
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Statesville, North Carolina, 28625
- Not yet recruiting
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Sugar Land, Texas, 77479
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Surprise, Arizona, 85374
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Tarzana, California, 91356
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Tinley Park, Illinois, 60477
- Withdrawn
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Topeka, Kansas, 66606
- Not yet recruiting
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Troy, Michigan, 48098
- Not yet recruiting
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Tucker, Georgia, 30084
- Not yet recruiting
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Waterbury, Connecticut, 06708
- Suspended
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Wilmington, North Carolina, 28401
- Not yet recruiting
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Wilmington, North Carolina, 28403
China66 sites, 66 recruiting
- Not yet recruiting
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Baoding, 071000
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Beijing, 100029
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Beijing, 100034
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Beijing, 100037
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Beijing, 101199
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Beijing, 102218
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Changchun, 130021
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Changsha, 410008
- Not yet recruiting
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Changsha, 410015
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Changzhou, 213000
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Changzhou, 213100
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Chengdu, 610041
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Chenzhou, 423000
- Not yet recruiting
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Chongqing, 400010
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Dongguan, 523009
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Foshan, 528000
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Ganzhou, 341000
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Guangzhou, 510100
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Guangzhou, 510150
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Guangzhou, 510280
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Guangzhou, 510665
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Guiyang, 550044
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Hefei, 230061
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Huangshi, 435000
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Huizhou, 516001
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Jiangmen, 529000
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Jining, 272006
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Linfen, 041099
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Luoyang, 471003
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Nanchang, 330006
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Nanjing, 210011
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Nanjing, 210029
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Nanning, 530000
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Nanning, 530021
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Nanning, 530022
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Ningbo, 315000
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Panjin, 124009
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Pingxiang, 337055
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Qingzhou, 262550
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Sacramento, 95816
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Shanghai, 200001
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Shanghai, 200240
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Shanghai, 201199
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Shantou, 515065
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Shenzhen, 518020
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Shenzhen, 518036
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Shenzhen, 518039
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Shenzhen, 518053
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Shijiazhuang, 50051
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Tianjin, 300000
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Tianjin, CN-300052
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Ürümqi, 831118
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Wuhan, 430010
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Wuhan, 430033
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Wuhan, 430060
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Wuxi, 214023
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Xi'an, 710068
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Xuzhou, 221000
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Yancheng, 224005
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Yangzhou, 225000
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Yantai, 264000
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Yibin, 644000
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Zhenjiang, 212002
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Zhongshan, 528401
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Zigong, 643000
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Zunyi, 563100
Japan57 sites, 54 recruiting
- Not yet recruiting
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Aira, 899-5421
- Not yet recruiting
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Akita, 010-8543
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Asahikawa-shi, 070-8530
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Chūōku, 103-0002
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Fujisawa-shi, 251-0041
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Fukuoka, 814-0180
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Fukuoka, 815-0033
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Hachioji-shi, 192-0083
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Hamamatsu, 431-3192
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Hiroshima, 734-8551
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Ichikawa-shi, 272-8516
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Ina-shi, 396-8555
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Iruma-Gun, 350-0495
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Izunokuni-shi, 410-2295
- Recruiting
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Kamakura-shi, 247-0056
- Not yet recruiting
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Kamiina-gun, 399-4511
- Not yet recruiting
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Kanazawa, 920-8650
- Withdrawn
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Kasuga-shi, 816-0864
- Not yet recruiting
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Kasugai-shi, 486-8510
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Kawachinagano-shi, 586-8521
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Kitakyushu, 802-8555
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Kitakyushu-shi, 802-0077
- Withdrawn
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Kumamoto, 862-0950
- Not yet recruiting
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Kurume, 830-8543
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Kuwana-shi, 511-0061
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Matsumoto-shi, 390-1401
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Minatoku, 108-0073
- Recruiting
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Minokamo Shi, 505-8510
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Moriyama-shi, 524-8524
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Nagoya, 451-8511
- Recruiting
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Nagoya, 468-0009
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Naka, 311-0113
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Naka, 311-0133
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Ōita, 870-0039
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Okayama, 700-0804
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Okayama, 700-8557
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Osaka, 558-8558
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Osaka, 559-0012
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Oyama-shi, 323-0022
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Sakaishi, 593-8304
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Sakushu, 385-8558
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Sapporo, 006-0852
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Sapporo, 060-0062
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Sapporo, 062-0931
- Withdrawn
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Sasebo-shi, 857-8511
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Shinjuku-ku, 160-0023
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Suita-shi, 564-8565
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Suita-shi, 565-0871
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Suwa-shi, 392-8510
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Takasago-shi, 676-0812
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Tsu, 514-8507
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Ueda-shi, 386-8610
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Ushiku-shi, 300-1207
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Utsunomiya, 321-0151
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Yokohama, 230-8765
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Yokohama, 234-0054
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Yokohama, 236-0004
Germany49 sites, 41 recruiting
- Not yet recruiting
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Ahrensburg, 22926
- Not yet recruiting
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Bad Mergentheim, 97980
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Bad Nenndorf, 31542
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Berlin, 10117
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Berlin, 10249
- Not yet recruiting
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Berlin, 10787
- Withdrawn
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Berlin, 12203
- Withdrawn
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Bonn, 53127
- Not yet recruiting
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Brandenburg an der Havel, 14770
- Not yet recruiting
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Braunschweig, 38126
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Chemnitz, 09116
- Not yet recruiting
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Cloppenburg, 49661
- Withdrawn
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Cuxhaven, 27472
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Dortmund, 44137
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Dresden, 1307
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Duisburg, 47269
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Erlangen, 91054
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Essen, 45122
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Frankfurt, 60596
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Frankfurt am Main, 60431
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Freiburg im Breisgau, 79110
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Fulda, 36037
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Gladbeck, 45968
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Goslar, 38642
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Göttingen, 37075
- Suspended
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Hamburg, 21109
- Withdrawn
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Hamburg, 22041
- Not yet recruiting
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Hamburg, 22143
- Suspended
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Hanover, 30159
- Not yet recruiting
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Hanover, 30625
- Not yet recruiting
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Heidelberg, 69120
- Not yet recruiting
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Herne, 44625
- Withdrawn
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Jerichow, 39319
- Not yet recruiting
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Kiel, 24105
- Not yet recruiting
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Landshut, 84034
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Leipzig, 04177
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Leipzig, 04179
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Lübeck, 23552
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Magdeburg, 39120
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Mannheim, 68167
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Nuremberg, 90443
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Nuremberg, 90471
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Reinfeld (Holstein), 23858
- Not yet recruiting
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Riesa, 01589
- Suspended
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Rostock, 18057
- Recruiting
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Stuttgart, 70376
- Not yet recruiting
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Ulm, 89081
- Not yet recruiting
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Wiesbaden, 65189
- Not yet recruiting
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Würzburg, 97080
India24 sites, 24 recruiting
- Not yet recruiting
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Aligarh, 202002
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Bangalore, 560060
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Bangalore, 560092
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Belagavi, 590006
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Bhubaneswar, 751019
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Calicut, 673 008
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Chennai, 600037
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Dehradun, 248001
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Delhi, 110062
- Not yet recruiting
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Gūrgaon, 122001
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Guwahati, 781032
- Not yet recruiting
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Haryāna, 124001
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Hyderabad, 500028
- Not yet recruiting
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Hyderabad, 500082
- Not yet recruiting
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Kolkata, 700014
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Kottayam, 686008
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Mumbai, 400012
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Mysuru, 570004
- Not yet recruiting
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New Delhi, 110001
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New Delhi, 110017
- Not yet recruiting
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New Delhi, 110029
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Noida, 201310
- Not yet recruiting
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Secunderabad, 500003
- Not yet recruiting
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Varanasi, 221 005
Brazil20 sites, 20 recruiting
- Not yet recruiting
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Barretos, 14784-400
- Not yet recruiting
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Belém, 66073-005
- Not yet recruiting
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Belo Horizonte, 30150-320
- Not yet recruiting
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Bragança Paulista, 12916-542
- Not yet recruiting
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Brasília, 71625-009
- Not yet recruiting
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Campina Grande do Sul, 83.430-000
- Not yet recruiting
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Campinas, 13060-080
- Not yet recruiting
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Campinas, 13092133
- Not yet recruiting
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Curitiba, 80810-040
- Not yet recruiting
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Joinville, 89227-680
- Not yet recruiting
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Natal, 59020-035
- Not yet recruiting
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Porto Alegre, 90020-090
- Not yet recruiting
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Porto Alegre, 9061-000
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Porto Alegre, 90630-165
- Not yet recruiting
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Presidente Prudente, 19050-680
- Not yet recruiting
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São José dos Campos, 12230-001
- Not yet recruiting
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São Paulo, 01228-000
- Not yet recruiting
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São Paulo, 01327-001
- Not yet recruiting
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São Paulo, 04038-031
- Not yet recruiting
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São Paulo, 05403-9000
Canada19 sites, 19 recruiting
- Not yet recruiting
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Calgary, Alberta, T2R0X7
- Not yet recruiting
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Calgary, Alberta, T3R 1W9
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Edmonton, Alberta, T6G 2B7
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London, Ontario, N6A 5A5
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London, Ontario, N6A 5W9
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2X 0A9
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Montreal, Quebec, H3G 1A4
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Montreal, Quebec, H4J 1C5
- Not yet recruiting
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Saint John, New Brunswick, E2L 4L2
- Not yet recruiting
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Scarborough Village, Ontario, M1H 3G4
- Not yet recruiting
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Sherbrooke, Quebec, J1H 5N4
- Recruiting
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Toronto, Ontario, M4G 3E8
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Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 2N2
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Toronto, Ontario, M6G 1M2
- Not yet recruiting
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Vancouver, British Columbia, V5Y 3W2
- Recruiting
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Waterloo, Ontario, N2T 0C1
- Not yet recruiting
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Winnipeg, Manitoba, R2V 3M3
Italy18 sites, 18 recruiting
- Not yet recruiting
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Alessandria, 15100
- Not yet recruiting
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Bari, 70124
- Not yet recruiting
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Bologna, 40138
- Not yet recruiting
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Catania, 95125
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Chieri, 10023
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Cinisello Balsamo, 20092
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Cosenza, 87100
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Eboli, 84025
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Feltre, 32032
- Not yet recruiting
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Foggia, 71100
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Naples, 80131
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Pavia, 27100
- Not yet recruiting
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Pordenone, 33170
- Not yet recruiting
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Ranica, 24020
- Not yet recruiting
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Rome, 00189
- Not yet recruiting
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San Fermo della Battaglia, 22020
- Not yet recruiting
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San Giovanni Rotondo, 71013
- Not yet recruiting
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Trieste, 34149
Poland18 sites, 17 recruiting
- Not yet recruiting
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Będzin, 42-500
- Not yet recruiting
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Bialystok, 15-481
- Not yet recruiting
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Czeladź, 41-250
- Not yet recruiting
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Gmina Świecie, 86-100
- Not yet recruiting
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Katowice, 40-648
- Not yet recruiting
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Kwidzyn, 82-500
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Lodz, 92-213
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Lublin, 20-011
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Olsztyn, 10-117
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Olsztyn, 10-561
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Poznan, 60-355
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Tczew, 83-110
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Warsaw, 00-719
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Warsaw, 04-141
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Włocławek, 87-800
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Żywiec, 34-300
United Kingdom18 sites, 18 recruiting
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Aberdeen, AB25 2ZN
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Cardiff, CF14 4XW
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Corby, NN18 9EZ
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Coventry, CV3 4FJ
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Leicester, LE9 7RT
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Liverpool, L9 7AL
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London, E1 1FR
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London, SE5 9RS
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Metropolitan Borough of Wirral, CH48 5AA
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Portsmouth, PO6 3LY
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Swansea, SN6 6NL
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Thetford, IP24 1JD
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York, YO21 8HE
Norway17 sites, 17 recruiting
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Bergen, 5021
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Bodø, 8005
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Drammen, 3004
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Grålum, 1714
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Haugesund, 5528
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Levanger, 7601
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Lørenskog, 1478
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Oslo, 0450
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Oslo, 0456
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Oslo, 0586
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Skedsmokorset, N-2020
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Stavanger, N-4011
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Tønsberg, 3116
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Tromsø, N-9038
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Trondheim, 7006
Malaysia16 sites, 16 recruiting
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Kota Bharu, 15586
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Kota Kinabalu, 88200
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Kuala Lumpur, 50450
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Kuala Lumpur, 50586
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Kuala Lumpur, 56000
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Kuala Lumpur, 59100
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Kuala Pilah, 72000
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Petaling Jaya, 47500
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Sarawak Miri, 98000
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Seri Manjung, 32040
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Taiping, 34000
Taiwan16 sites, 16 recruiting
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Changhua, 500
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Kaohsiung City, 81362
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New Taipei City, 23561
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Taichung, 40447
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Taichung, 407219
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Tainan, 704
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Tainan, 73657
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Taipei, 110
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Taipei, 11696
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Taoyuan, 333
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Argentina14 sites, 13 recruiting
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Buenos Aires, C1056
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Buenos Aires, C1060AAB
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CABA, C1425HFA
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Ciudad de Buenos Aires, 1128
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Ciudad de Buenos Aires, C1094AAD
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Córdoba, X5006CBI
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La Plata, B1900
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Mar del Plata, 7600
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Mar del Plata, B7600
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Rosario, 2000
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Rosario, S2000CVD
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San Nicolás, B2900DMH
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Santa Rosa, 6300
Czechia14 sites, 12 recruiting
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Hradec Králové, 50005
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Liberec, 46014
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Mariánské Lázně, 35301
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Nové Město na Moravě, 692 31
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Prague, 100 34
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Prague, 130 00
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Prague, 160 00
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Tábor, 390 03
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France14 sites, 14 recruiting
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Corbeil-Essonnes, 91100
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Grenoble, 38043
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Indonesia14 sites, 14 recruiting
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Kabupaten Sukoharjo, 57161
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Kota Padang, 25171
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Tangerang, 15117
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Peru14 sites, 14 recruiting
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Piura, 20001
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Piura, 20009
Romania14 sites, 14 recruiting
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Bucharest, 010507
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Bucharest, 011053
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Bucharest, 031141
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Bucharest, 060044
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Bucharest, 22328
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Cluj-Napoca, 400349
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Iași, 700515
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Oradea, 410001
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Oradea, 410032
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Oradea, 410469
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Oradea, 410562
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Ploieşti, 100179
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Timișoara, 300723
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Timișoara, 300736
South Korea14 sites, 14 recruiting
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Anyang-si, 14068
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Busan, 48108
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Busan, 49241
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Cheonan-si, 31151
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Daejeon, 34943
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Goyang-si, 10380
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Guri-si, 11923
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Junggu, 41944
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Seoul, 03080
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Seoul, 03722
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Seoul, 04401
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Seoul, 06591
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Seoul, 08308
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Seoul, 5505
Thailand14 sites, 14 recruiting
- Not yet recruiting
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Bangkok, 10210
- Not yet recruiting
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Bangkok, 10220
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Bangkok, 10300
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Bangkok, 10330
- Not yet recruiting
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Bangkok, 10400
- Not yet recruiting
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Bangkok, 10700
- Not yet recruiting
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Banphaeo, 74120
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Hat Yai, 90110
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Khlong Luang, 12120
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Muang, 50200
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Phitsanulok, 65000
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Phutthamonthon, 73170
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Ratchaburi, 70000
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Ubonratchathani, 34000
Vietnam13 sites, 11 recruiting
- Not yet recruiting
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Can Tho, 900000
- Not yet recruiting
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Da Nang, 55000
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Hà Nội, 100000
- Not yet recruiting
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Haiphong, 180000
- Not yet recruiting
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Hanoi, 100000
- Withdrawn
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Hanoi, 100000
- Not yet recruiting
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Hanoi, 10000
- Not yet recruiting
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Hồ Chí Minh, 700000
- Not yet recruiting
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Ho Chi Minh City, 7000000
- Not yet recruiting
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Ho Chi Minh City, 700000
- Suspended
Research Site
Ho Chi Minh City, 700000
- Not yet recruiting
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Ho Chi Minh City, 70000
- Not yet recruiting
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Hochiminh City, 700000
Greece12 sites, 11 recruiting
- Not yet recruiting
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Alexandroupoli, 68100
- Not yet recruiting
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Athens, 11527
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Athens, 12462
- Not yet recruiting
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Athens, 15125
- Not yet recruiting
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Chios, 82100
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Heraklion, 71500
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Ioannina, 45500
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Larissa, 41500
- Not yet recruiting
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Pátrai, 26504
- Suspended
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Thessaloniki, 54642
- Not yet recruiting
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Thessaloniki, 54645
- Not yet recruiting
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Thessaloniki, 57001
Spain12 sites, 12 recruiting
- Not yet recruiting
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Badajoz, 06080
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Barcelona, 08035
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Barcelona, 08036
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Burgos, 09006
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Córdoba, 14004
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Granada, 18014
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Madrid, 28041
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Majadahonda, 28222
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Málaga, 29010
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Pamplona, 31008
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Valencia, 46010
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Valencia, 46026
Bulgaria11 sites, 11 recruiting
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Botevgrad, 2140
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Byala Slatina, 3200
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Pleven, 5800
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Plovdiv, 4000
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Plovdiv, 4001
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Plovdiv, 4004
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Sofia, 1407
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Sofia, 1756
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Varna, 9000
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Varna, 9010
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Yambol, 8600
Ukraine11 sites, 11 recruiting
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Ivano-Frankivsk, 76018
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Kyiv, 01601
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Kyiv, 02002
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Vinnytsia, 21029
Hungary10 sites, 10 recruiting
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Budapest, 1033
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Budapest, 1085
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Nagykanizsa, 8800
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Szeged, 6725
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Israel10 sites, 10 recruiting
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Ashkelon, 78278
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Be’er Ya‘aqov, 70300
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Haifa, 34362
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Kfar Saba, 4428164
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Nahariya, 22100
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Ramat Gan, 52621
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Rehovot, 76100
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Tiberias, 15208
Sweden10 sites, 10 recruiting
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Falun, 79182
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Gothenburg, 41345
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Karlstad, 651 85
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Linköping, 581 85
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Örebro, 70185
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Stockholm, 141 86
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Stockholm, SE-18288
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Uppsala, 75185
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Vaxjo, 352 34
Australia9 sites, 9 recruiting
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Castle Hill, 2154
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Fitzroy, 3065
- Recruiting
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Gosford, 2250
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Melbourne, 3004
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Perth, 6000
- Recruiting
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Southport, 4215
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St Leonards, 2065
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Wollongong, 2500
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Woolloongabba, 4102
Chile9 sites, 9 recruiting
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Araucania, 4781151
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Osorno, 5311092
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Region Metropolitana, 7550000
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Santiago, 7510187
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Santiago, 8330034
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Santiago
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Temuco, 4810345
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Victoria, 4720000
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Viña del Mar, 2540488
Philippines9 sites, 9 recruiting
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Davao City, 8000
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Davao City, PH-8000
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Iloilo City, 5000
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Las Piñas, 1742
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Manadaluyong City, 1552
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Quezon City, 0870
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Quezon City, 1101
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Quezon City, 1112
Denmark7 sites, 7 recruiting
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Aalborg, 9000
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Aarhus, 8200
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Mexico7 sites, 7 recruiting
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Chihuahua City, 31238
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Culiacán, 80230
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Mérida, 97070
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Mérida, 97130
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Monterrey, 64060
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Zapopan, 45070
Serbia7 sites, 7 recruiting
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Belgrade, 11000
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Belgrade, 11070
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Belgrade, 11080
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Kragujevac, 34000
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Kruševac, 37000
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Niš, 18000
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Pančevo, 26101
Finland6 sites, 6 recruiting
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Helsinki, 00290
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Jyväskylä, 40620
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Oulu, 90220
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Tampere, 33100
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Tampere, 33101
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Turku, 20100
United Arab Emirates2 sites, 2 recruiting
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Abu Dhabi, 48338
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Abu Dhabi, 48481
About this study
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)
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Elecoglipron, Placebo
- Keywords
- Chronic kidney disease, Elecoglipron
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Elicoglipron tablet
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Elecoglipron | Experimental | Elecoglipron tablet once daily Receives: Drug: Elecoglipron |
| Placebo | Active comparator | Placebo matching Elecoglipron tablet once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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
Measured: Event-driven, trial is estimated to be up to 4.5 years
Secondary outcomes (9)
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 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
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke
Time to the first occurrence of any component of this composite:
- All-cause mortality
- MI
- Stroke
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)
Time to the first occurrence of any component of this composite:
- CV and renal death
- MI
- Stroke
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality
Time to death from any cause
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death
Time to death from CV cause
Measured: Event-driven, trial is estimated to be up to 4.5 years
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 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
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations
Time to the first occurrence of any component of this composite:
- CV death
- HF hospitalizations (hHF)
Measured: Event-driven, trial is estimated to be up to 4.5 years
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 to first occurrence of any component of this composite:
- CV death
- MI
- Stroke
- HF hospitalizations (hHF)
Measured: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization
Time to hospitalization for any cause
Measured: Event-driven, trial is estimated to be up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start21 Aug 2026
- Primary completion4 Oct 2030 (estimated)
- Study completion4 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753993
- Sponsor's protocol ID
- D7265C00001
- Other IDs
- 2025-523994-41-00, 2025
- Acronym
- Elevate-CKD
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07753993
- Acronym / sponsor ID
- Elevate-CKD / D7265C00001
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Elecoglipron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 4 Oct 2030 (estimated)
- Study completion
- 4 Oct 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elecoglipron | Experimental | Drug: ElecoglipronElecoglipron tablet once daily |
| Placebo | Active comparator | Drug: PlaceboPlacebo matching Elecoglipron tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElecoglipronElicoglipron tablet | Drug | Elecoglipron |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
715 sites in 37 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elecoglipron in people with Chronic Kidney Disease, run by AstraZeneca at 715 sites in 37 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 715 sites in United States, China, Japan, Germany, India and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.