RecruitingPhase 3NCT07662135

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

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)


Sponsor

AstraZeneca

Enrollment

900 participants

Start Date

Jul 6, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Elecoglipron and a drug called Placebo for people with type 2 diabetes mellitus and type 2 diabetes with chronic kidney disease. The study is currently recruiting participants at 169 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElecoglipron

Elecoglipron is administered orally once daily.

DRUGPlacebo

Placebo is administered orally once daily.


Locations(169)

Research Site

Peoria, 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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Braintree, Massachusetts, United States

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New Bedford, 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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Ogden, Utah, United States

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Arlington, Virginia, United States

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Rousse, 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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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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Kitakyushu, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Kyoto, Japan

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Maebashi, Japan

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Nagoya, Japan

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Osaka, Japan

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Sapporo, Japan

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Toyota-Shi, Japan

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Batu Caves, Malaysia

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Kuala Lumpur, Malaysia

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Miri, Malaysia

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Seremban, Malaysia

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Seri Manjung, Malaysia

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Chihuahua City, Mexico

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Cuernavaca, Mexico

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Cuernavaca, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Monterrey, Mexico

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Zapopan, Mexico

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Barcelona, Spain

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Ferrol, Spain

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Lleida, Spain

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Madrid, Spain

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Majadahonda, Spain

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Málaga, Spain

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Santander, Spain

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Seville, Spain

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Seville, Spain

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Seville, Spain

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Valencia, Spain

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Zaragoza, Spain

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Zhubei, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Ratchathewi, Thailand

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Bakırköy, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Yüreğir, Turkey (Türkiye)

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Lviv, Ukraine

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Vinnytsia, Ukraine

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Blackpool, United Kingdom

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Glasgow, United Kingdom

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Hull, United Kingdom

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Penzance, United Kingdom

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Sandbach, United Kingdom

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Thetford, United Kingdom

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Whitney, United Kingdom

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Haiphong, Vietnam

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Hanoi, Vietnam

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Hanoi, Vietnam

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Hà Nội, Vietnam

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Ho Chi Minh City, Vietnam

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Hochiminh City, Vietnam

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Viet Tri, Vietnam

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NCT07662135


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