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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
Sponsor: AstraZeneca
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
Official title: A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-07-06
Completion Date
2028-07-13
Last Updated
2026-09-02
Healthy Volunteers
No
Interventions
Elecoglipron
Elecoglipron is administered orally once daily.
Placebo
Placebo is administered orally once daily.
Locations (186)
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Sun City, Arizona, United States
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Surprise, Arizona, United States
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Concord, California, United States
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Sacramento, California, United States
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Victorville, California, United States
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Fleming Island, Florida, United States
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Lauderdale Lakes, Florida, United States
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Leesburg, Florida, United States
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Miami Lakes, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Braintree, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Worcester, Massachusetts, United States
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Saint Joseph, Michigan, United States
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Saint Paul, Minnesota, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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The Bronx, New York, United States
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Kinston, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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East Providence, Rhode Island, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Arlington, Virginia, United States
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Dupnitsa, Bulgaria
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Haskovo, Bulgaria
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Kyustendil, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Varna, Bulgaria
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Binzhou, China
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Changsha, China
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Chengdu, China
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Hangzhou, China
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Jinan, China
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Liaocheng, China
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Liuzhou, China
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Luoyang, China
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Nanjing, China
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Nanyang, China
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Suining Shi, China
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Yibin, China
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Yichang, China
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Zhengzhou, China
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Zhengzhou, China
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Aarhus N, Denmark
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Gistrup, Denmark
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Herlev, Denmark
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Hillerød, Denmark
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Holbæk, Denmark
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Hvidovre, Denmark
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Bad Oeynhausen, Germany
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Berlin, Germany
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Brandenburg an der Havel, Germany
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Chemnitz, Germany
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Duisburg, Germany
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Duisburg, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heilbronn, Germany
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Hohenmölsen, Germany
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Ludwigshafen, Germany
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Münster, Germany
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Nittendorf, Germany
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Obertshausen, Germany
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Pirna, Germany
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Sankt Ingbert, Germany
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Stuttgart, Germany
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Aligarh, India
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Belagavi, India
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Belgavi, India
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Calicut, India
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Chennai, India
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Chennai, India
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Coimbatore, India
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Delhi, India
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Guntur, India
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Kolkata, India
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Lucknow, India
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Nagpur, India
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Pune, India
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Chigasaki-shi, Japan
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Chikushino-shi, Japan
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Gifu, Japan
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Kagoshima, Japan
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Kitakyushu, Japan
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Kumamoto, Japan