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)
Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
• On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
• HbA1c value:
‣ On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
⁃ SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
• Impaired renal function
• Body mass index (BMI) of ≥ 23 kg/m2 at screening
• Stable body weight (self-reported or documented) for 90 days prior to screening
Locations
United States
Arizona
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NOT_YET_RECRUITING
Sun City
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Surprise
California
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Concord
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RECRUITING
Sacramento
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Victorville
Florida
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Fleming Island
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Lauderdale Lakes
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Leesburg
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Miami Lakes
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Ocoee
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Orlando
Illinois
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Chicago
Massachusetts
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Braintree
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New Bedford
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Worcester
Michigan
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SUSPENDED
Saint Joseph
Minnesota
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Saint Paul
Missouri
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Kansas City
North Carolina
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Kinston
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Raleigh
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Winston-salem
Nebraska
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Omaha
New Mexico
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RECRUITING
Albuquerque
Nevada
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NOT_YET_RECRUITING
Las Vegas
New York
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NOT_YET_RECRUITING
The Bronx
Ohio
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Cincinnati
Rhode Island
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East Providence
South Carolina
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RECRUITING
Gaffney
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Greenville
Texas
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San Antonio
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SUSPENDED
San Antonio
Utah
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NOT_YET_RECRUITING
Ogden
Virginia
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SUSPENDED
Arlington
Other Locations
Bulgaria
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NOT_YET_RECRUITING
Dupnitsa
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Haskovo
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Kyustendil
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NOT_YET_RECRUITING
Pleven
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NOT_YET_RECRUITING
Plovdiv
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Rousse
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Stara Zagora
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Varna
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Varna
China
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Binzhou
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Changsha
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Chengdu
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Hangzhou
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Jinan
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Liaocheng
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Liuzhou
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Luoyang
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Nanjing
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Nanyang
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Suining Shi
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Yibin
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Yichang
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Zhengzhou
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Zhengzhou
Denmark
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NOT_YET_RECRUITING
Aarhus N
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Gistrup
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Herlev
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Hillerød
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Holbæk
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Hvidovre
Germany
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Bad Oeynhausen
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Berlin
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WITHDRAWN
Brandenburg An Der Havel
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Chemnitz
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Duisburg
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Duisburg
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Erlangen
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Frankfurt
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Hamburg
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Heilbronn
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Hohenmölsen
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Ludwigshafen
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SUSPENDED
Münster
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NOT_YET_RECRUITING
Nittendorf
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Obertshausen
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Pirna
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SUSPENDED
Sankt Ingbert
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Stuttgart
India
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Aligarh
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Belagavi
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Belgavi
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Calicut
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Chennai
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Chennai
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Coimbatore
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Delhi
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Guntur
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Kolkata
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Lucknow
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Nagpur
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Pune
Japan
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Chigasaki-shi
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Chikushino-shi
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RECRUITING
Gifu
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Kagoshima
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Kitakyushu
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Kumamoto
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Kyoto
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Kyoto
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Maebashi
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Nagoya
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Nagoya
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Osaka
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Sapporo
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Suita-shi
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Tachikawa-shi
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Toyota-shi
Malaysia
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Batu Caves
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Kuala Lumpur
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Miri
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Seremban
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Seri Manjung
Mexico
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Chihuahua City
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Cuernavaca
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Cuernavaca
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Guadalajara
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Guadalajara
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Guadalajara
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Mexico City
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Monterrey
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Monterrey
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Zapopan
Spain
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Barcelona
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Ferrol
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Lleida
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Madrid
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Majadahonda
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Málaga
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Santander
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Seville
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Seville
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Seville
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Valencia
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Zaragoza
Taiwan
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Kaohsiung City
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New Taipei City
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New Taipei City
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Taichung
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Taichung
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Taichung
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Tainan
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Taipei
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Taipei
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Taoyuan
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Zhubei
Thailand
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NOT_YET_RECRUITING
Bangkok
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Bangkok
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Chiang Mai
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Hat Yai
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Muang
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Ratchathewi
Turkey
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Adana
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Ankara
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Antalya
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Bakırköy
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Gaziantep
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Kayseri
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Kayseri
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Yüreğir
Ukraine
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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NOT_YET_RECRUITING
Kyiv
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NOT_YET_RECRUITING
Lviv
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Lviv
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NOT_YET_RECRUITING
Vinnytsia
United Kingdom
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RECRUITING
Blackpool
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NOT_YET_RECRUITING
Glasgow
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NOT_YET_RECRUITING
Hull
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NOT_YET_RECRUITING
Penzance
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RECRUITING
Sandbach
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RECRUITING
Thetford
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NOT_YET_RECRUITING
Whitney
Viet Nam
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NOT_YET_RECRUITING
Hà Nội
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NOT_YET_RECRUITING
Haiphong
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NOT_YET_RECRUITING
Hanoi
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NOT_YET_RECRUITING
Hanoi
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NOT_YET_RECRUITING
Ho Chi Minh City
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NOT_YET_RECRUITING
Hochiminh City
Research Site
WITHDRAWN
Viet Tri
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-07-06
Estimated Completion Date: 2028-07-13
Participants
Target number of participants: 900
Treatments
Experimental: Elecoglipron dose level 1
Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.
Experimental: Elecoglipron dose level 2
Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
Placebo_comparator: Placebo
Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca