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
Eluminate-4
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)
2 other identifiers
interventional
900
16 countries
169
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jul 2026
Typical duration for phase_3 type-2-diabetes-mellitus
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 23, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 13, 2028
July 15, 2026
July 1, 2026
2 years
June 18, 2026
July 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Hemoglobin A1c (HbA1c)
Baseline to Week 40
Secondary Outcomes (9)
Achievement of HbA1c < 7% (53 mmol/mol)
Week 40
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Week 40
Percent change in body weight
Baseline to Week 40
Change from baseline in body weight
Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
Baseline to Week 40
- +4 more secondary outcomes
Study Arms (3)
Elecoglipron dose level 1
EXPERIMENTALParticipants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.
Elecoglipron dose level 2
EXPERIMENTALParticipants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
Placebo
PLACEBO COMPARATORParticipants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.
Interventions
Elecoglipron is administered orally once daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- 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 has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- 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
- Severe congestive heart failure (New York Heart Association IV)
- History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (169)
Research Site
Peoria, Arizona, 85382, United States
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Surprise, Arizona, 85374, United States
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Concord, California, 94520, United States
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Sacramento, California, 95821, United States
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Victorville, California, 92392, United States
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Fleming Island, Florida, 32003, United States
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Lauderdale Lakes, Florida, 33313, United States
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Leesburg, Florida, 34748, United States
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Miami Lakes, Florida, 33016, United States
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Ocoee, Florida, 34761, United States
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Orlando, Florida, 32804, United States
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Braintree, Massachusetts, 02184, United States
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New Bedford, Massachusetts, 02740, United States
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Saint Joseph, Michigan, 49085, United States
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Saint Paul, Minnesota, 55117, United States
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Kansas City, Missouri, 64111, United States
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Omaha, Nebraska, 68144, United States
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Las Vegas, Nevada, 89119, United States
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Albuquerque, New Mexico, 87102, United States
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The Bronx, New York, 10451, United States
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Kinston, North Carolina, 28504, United States
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Raleigh, North Carolina, 27609, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45219, United States
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East Providence, Rhode Island, 02914, United States
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Gaffney, South Carolina, 29340, United States
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Greenville, South Carolina, 29605, United States
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San Antonio, Texas, 78257, United States
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Ogden, Utah, 84405, United States
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Arlington, Virginia, 22205, United States
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Rousse, 7000, Bulgaria
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Binzhou, 256606, China
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Changsha, 430033, China
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Chengdu, 610081, China
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Hangzhou, 310006, China
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Jinan, 250013, China
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Liaocheng, 252000, China
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Liuzhou, 545006, China
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Luoyang, 471003, China
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Nanjing, 211100, China
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Nanyang, 473000, China
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Suining Shi, 629000, China
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Yibin, 610500, China
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Yichang, 443003, China
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Zhengzhou, 450002, China
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Zhengzhou, 450012, China
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Aarhus N, 8200, Denmark
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Gistrup, 9260, Denmark
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Herlev, 2730, Denmark
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Hillerød, 3400, Denmark
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Holbæk, 4300, Denmark
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Hvidovre, 2650, Denmark
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Bad Oeynhausen, 32545, Germany
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Berlin, 12047, Germany
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Brandenburg an der Havel, 14776, Germany
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Chemnitz, 09116, Germany
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Duisburg, 47051, Germany
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Duisburg, 47269, Germany
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Erlangen, 91054, Germany
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Frankfurt, 60596, Germany
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Hamburg, 22607, Germany
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Heilbronn, 74076, Germany
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Hohenmölsen, 06679, Germany
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Ludwigshafen, 67059, Germany
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Münster, 48153, Germany
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Nittendorf, 93152, Germany
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Obertshausen, 63179, Germany
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Pirna, 01796, Germany
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Sankt Ingbert, 66386, Germany
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Stuttgart, 70174, Germany
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Aligarh, 202002, India
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Belagavi, 590006, India
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Belgavi, 590010, India
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Chennai, 600037, India
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Chennai, 600086, India
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Coimbatore, 641018, India
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Delhi, 110029, India
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Guntur, 522001, India
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Kolkata, 700020, India
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Lucknow, 226030, India
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Nagpur, 440010, India
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Pune, 411021, India
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Chigasaki-shi, 253-0044, Japan
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Chikushino-shi, 8188502, Japan
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Gifu, 501-1194, Japan
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Kitakyushu, 805-8508, Japan
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Kumamoto, 862-0965, Japan
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Kyoto, 605-0981, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8511, Japan
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Nagoya, 468-0009, Japan
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Osaka, 559-0012, Japan
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Sapporo, 060-0062, Japan
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Toyota-Shi, 471-8513, Japan
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Batu Caves, 68100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Miri, 98000, Malaysia
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Seremban, 70300, Malaysia
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Seri Manjung, 32040, Malaysia
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Chihuahua City, 31238, Mexico
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Cuernavaca, 62250, Mexico
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Cuernavaca, 62448, Mexico
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Guadalajara, 44600, Mexico
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Guadalajara, 44670, Mexico
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Mexico City, 0 3100, Mexico
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Monterrey, 64030, Mexico
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Monterrey, 64460, Mexico
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Zapopan, 45116, Mexico
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Barcelona, 08035, Spain
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Ferrol, 15405, Spain
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Lleida, 25198, Spain
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Madrid, 28040, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Santander, 39008, Spain
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Seville, 41010, Spain
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Seville, 41013, Spain
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Seville, 41950, Spain
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Valencia, 46010, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 833401, Taiwan
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New Taipei City, 23561, Taiwan
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New Taipei City, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Tainan, 710, Taiwan
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Taipei, 100, Taiwan
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Taipei, 110, Taiwan
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Taoyuan, 333, Taiwan
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Zhubei, 302, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Muang, 70000, Thailand
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Ratchathewi, 10400, Thailand
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Adana, 01060, Turkey (Türkiye)
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Ankara, 06530, Turkey (Türkiye)
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Antalya, 07070, Turkey (Türkiye)
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Bakırköy, 34147, Turkey (Türkiye)
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Gaziantep, 27470, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kayseri, 38080, Turkey (Türkiye)
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Yüreğir, 1240, Turkey (Türkiye)
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Kyiv, 01601, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03057, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04210, Ukraine
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Lviv, 79010, Ukraine
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Lviv, 79016, Ukraine
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Vinnytsia, 21029, Ukraine
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Blackpool, FY3 7EN, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Penzance, TR18 3DX, United Kingdom
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Sandbach, CW11 1EQ, United Kingdom
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Thetford, IP24 1JD, United Kingdom
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Whitney, OX29 4QB, United Kingdom
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Haiphong, 180000, Vietnam
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh City, 700000, Vietnam
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Viet Tri, 35000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 23, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
July 13, 2028
Study Completion (Estimated)
July 13, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.