RecruitingRecruiting
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
NCT07662135 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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 criteria
Inclusion Criteria:
* 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:
1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
2. 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-07-06
Estimated completion: 2028-07-13
Last updated: 2026-09-02
Interventions
Drug: ElecoglipronDrug: Placebo
Primary outcomes
- • Change from baseline in Hemoglobin A1c (HbA1c) (Baseline to Week 40)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (186)
Research SiteNot Yet Recruiting
Sun City, Arizona, United States
Research SiteNot Yet Recruiting
Surprise, Arizona, United States
Research SiteNot Yet Recruiting
Concord, California, United States
Research SiteRecruiting
Sacramento, California, United States
Research SiteNot Yet Recruiting
Victorville, California, United States
Research SiteNot Yet Recruiting
Fleming Island, Florida, United States
Research SiteNot Yet Recruiting
Lauderdale Lakes, Florida, United States
Research SiteNot Yet Recruiting
Leesburg, Florida, United States
Research SiteRecruiting
Miami Lakes, Florida, United States
Research SiteRecruiting
Ocoee, Florida, United States
Research SiteNot Yet Recruiting
Orlando, Florida, United States
Research SiteNot Yet Recruiting
Chicago, Illinois, United States
Research SiteNot Yet Recruiting
Braintree, Massachusetts, United States
Research SiteNot Yet Recruiting
New Bedford, Massachusetts, United States
Research SiteNot Yet Recruiting
Worcester, Massachusetts, United States
Research SiteSuspended
Saint Joseph, Michigan, United States
Research SiteNot Yet Recruiting
Saint Paul, Minnesota, United States
Research SiteRecruiting
Kansas City, Missouri, United States
Research SiteNot Yet Recruiting
Omaha, Nebraska, United States
Research SiteNot Yet Recruiting
Las Vegas, Nevada, United States
Research SiteRecruiting
Albuquerque, New Mexico, United States
Research SiteNot Yet Recruiting
The Bronx, New York, United States
Research SiteNot Yet Recruiting
Kinston, North Carolina, United States
Research SiteRecruiting
Raleigh, North Carolina, United States
Research SiteNot Yet Recruiting
Winston-Salem, North Carolina, United States
Research SiteNot Yet Recruiting
Cincinnati, Ohio, United States
Research SiteNot Yet Recruiting
East Providence, Rhode Island, United States
Research SiteRecruiting
Gaffney, South Carolina, United States
Research SiteNot Yet Recruiting
Greenville, South Carolina, United States
Research SiteSuspended
San Antonio, Texas, United States
Research SiteNot Yet Recruiting
San Antonio, Texas, United States
Research SiteNot Yet Recruiting
Ogden, Utah, United States
Research SiteSuspended
Arlington, Virginia, United States
Research SiteNot Yet Recruiting
Dupnitsa, Bulgaria
Research SiteNot Yet Recruiting
Haskovo, Bulgaria
Research SiteNot Yet Recruiting
Kyustendil, Bulgaria
Research SiteNot Yet Recruiting
Pleven, Bulgaria
Research SiteNot Yet Recruiting
Plovdiv, Bulgaria
Research SiteNot Yet Recruiting
Rousse, Bulgaria
Research SiteNot Yet Recruiting
Stara Zagora, Bulgaria
Research SiteNot Yet Recruiting
Varna, Bulgaria
Research SiteNot Yet Recruiting
Varna, Bulgaria
Research SiteNot Yet Recruiting
Binzhou, China
Research SiteNot Yet Recruiting
Changsha, China
Research SiteNot Yet Recruiting
Chengdu, China
Research SiteNot Yet Recruiting
Hangzhou, China
Research SiteNot Yet Recruiting
Jinan, China
Research SiteNot Yet Recruiting
Liaocheng, China
Research SiteNot Yet Recruiting
Liuzhou, China
Research SiteNot Yet Recruiting
Luoyang, China
Research SiteNot Yet Recruiting
Nanjing, China
Research SiteNot Yet Recruiting
Nanyang, China
Research SiteNot Yet Recruiting
Suining Shi, China
Research SiteNot Yet Recruiting
Yibin, China
Research SiteNot Yet Recruiting
Yichang, China
Research SiteNot Yet Recruiting
Zhengzhou, China
Research SiteNot Yet Recruiting
Zhengzhou, China
Research SiteNot Yet Recruiting
Aarhus N, Denmark
Research SiteNot Yet Recruiting
Gistrup, Denmark
Research SiteNot Yet Recruiting
Herlev, Denmark
Research SiteNot Yet Recruiting
Hillerød, Denmark
Research SiteNot Yet Recruiting
Holbæk, Denmark
Research SiteNot Yet Recruiting
Hvidovre, Denmark
Research SiteNot Yet Recruiting
Bad Oeynhausen, Germany
Research SiteNot Yet Recruiting
Berlin, Germany
Research SiteWithdrawn
Brandenburg an der Havel, Germany
Research SiteNot Yet Recruiting
Chemnitz, Germany
Research SiteNot Yet Recruiting
Duisburg, Germany
Research SiteNot Yet Recruiting
Duisburg, Germany
Research SiteNot Yet Recruiting
Erlangen, Germany
Research SiteNot Yet Recruiting
Frankfurt, Germany
Research SiteNot Yet Recruiting
Hamburg, Germany
Research SiteNot Yet Recruiting
Heilbronn, Germany
Research SiteNot Yet Recruiting
Hohenmölsen, Germany
Research SiteNot Yet Recruiting
Ludwigshafen, Germany
Research SiteSuspended
Münster, Germany
Research SiteNot Yet Recruiting
Nittendorf, Germany
Research SiteNot Yet Recruiting
Obertshausen, Germany
Research SiteNot Yet Recruiting
Pirna, Germany
Research SiteSuspended
Sankt Ingbert, Germany
Research SiteNot Yet Recruiting
Stuttgart, Germany
Research SiteNot Yet Recruiting
Aligarh, India
Research SiteNot Yet Recruiting
Belagavi, India
Research SiteNot Yet Recruiting
Belgavi, India
Research SiteNot Yet Recruiting
Calicut, India
Research SiteNot Yet Recruiting
Chennai, India
Research SiteNot Yet Recruiting
Chennai, India
Research SiteNot Yet Recruiting
Coimbatore, India
Research SiteNot Yet Recruiting
Delhi, India
Research SiteNot Yet Recruiting
Guntur, India
Research SiteNot Yet Recruiting
Kolkata, India
Research SiteNot Yet Recruiting
Lucknow, India
Research SiteNot Yet Recruiting
Nagpur, India
Research SiteNot Yet Recruiting
Pune, India
Research SiteNot Yet Recruiting
Chigasaki-shi, Japan
Research SiteNot Yet Recruiting
Chikushino-shi, Japan
Research SiteRecruiting
Gifu, Japan
Research SiteNot Yet Recruiting
Kagoshima, Japan
Research SiteNot Yet Recruiting
Kitakyushu, Japan
Research SiteNot Yet Recruiting
Kumamoto, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Maebashi, Japan
Research SiteNot Yet Recruiting
Nagoya, Japan
Research SiteRecruiting
Nagoya, Japan
Research SiteNot Yet Recruiting
Osaka, Japan
Research SiteNot Yet Recruiting
Sapporo, Japan
Research SiteNot Yet Recruiting
Suita-shi, Japan
Research SiteNot Yet Recruiting
Tachikawa-shi, Japan
Research SiteRecruiting
Toyota-Shi, Japan
Research SiteNot Yet Recruiting
Batu Caves, Malaysia
Research SiteNot Yet Recruiting
Kuala Lumpur, Malaysia
Research SiteNot Yet Recruiting
Miri, Malaysia
Research SiteNot Yet Recruiting
Seremban, Malaysia
Research SiteNot Yet Recruiting
Seri Manjung, Malaysia
Research SiteNot Yet Recruiting
Chihuahua City, Mexico
Research SiteNot Yet Recruiting
Cuernavaca, Mexico
Research SiteNot Yet Recruiting
Cuernavaca, Mexico
Research SiteNot Yet Recruiting
Guadalajara, Mexico
Research SiteNot Yet Recruiting
Guadalajara, Mexico
Research SiteNot Yet Recruiting
Guadalajara, Mexico
Research SiteNot Yet Recruiting
Mexico City, Mexico
Research SiteNot Yet Recruiting
Monterrey, Mexico
Research SiteNot Yet Recruiting
Monterrey, Mexico
Research SiteNot Yet Recruiting
Zapopan, Mexico
Research SiteNot Yet Recruiting
Barcelona, Spain
Research SiteNot Yet Recruiting
Ferrol, Spain
Research SiteNot Yet Recruiting
Lleida, Spain
Research SiteNot Yet Recruiting
Madrid, Spain
Research SiteNot Yet Recruiting
Majadahonda, Spain
Research SiteNot Yet Recruiting
Málaga, Spain
Research SiteNot Yet Recruiting
Santander, Spain
Research SiteNot Yet Recruiting
Seville, Spain
Research SiteNot Yet Recruiting
Seville, Spain
Research SiteNot Yet Recruiting
Seville, Spain
Research SiteNot Yet Recruiting
Valencia, Spain
Research SiteNot Yet Recruiting
Zaragoza, Spain
Research SiteRecruiting
Kaohsiung City, Taiwan
Research SiteNot Yet Recruiting
New Taipei City, Taiwan
Research SiteNot Yet Recruiting
New Taipei City, Taiwan
Research SiteNot Yet Recruiting
Taichung, Taiwan
Research SiteRecruiting
Taichung, Taiwan
Research SiteRecruiting
Taichung, Taiwan
Research SiteNot Yet Recruiting
Tainan, Taiwan
Research SiteRecruiting
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteRecruiting
Taoyuan, Taiwan
Research SiteRecruiting
Zhubei, Taiwan
Research SiteNot Yet Recruiting
Bangkok, Thailand
Research SiteNot Yet Recruiting
Bangkok, Thailand
Research SiteNot Yet Recruiting
Chiang Mai, Thailand
Research SiteNot Yet Recruiting
Hat Yai, Thailand
Research SiteNot Yet Recruiting
Muang, Thailand
Research SiteNot Yet Recruiting
Ratchathewi, Thailand
Research SiteNot Yet Recruiting
Adana, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Ankara, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Antalya, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Bakırköy, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Gaziantep, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Kayseri, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Kayseri, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Yüreğir, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Lviv, Ukraine
Research SiteNot Yet Recruiting
Lviv, Ukraine
Research SiteNot Yet Recruiting
Vinnytsia, Ukraine
Research SiteRecruiting
Blackpool, United Kingdom
Research SiteNot Yet Recruiting
Glasgow, United Kingdom
Research SiteNot Yet Recruiting
Hull, United Kingdom
Research SiteNot Yet Recruiting
Penzance, United Kingdom
Research SiteRecruiting
Sandbach, United Kingdom
Research SiteRecruiting
Thetford, United Kingdom
Research SiteNot Yet Recruiting
Whitney, United Kingdom
Research SiteNot Yet Recruiting
Haiphong, Vietnam
Research SiteNot Yet Recruiting
Hanoi, Vietnam
Research SiteNot Yet Recruiting
Hanoi, Vietnam
Research SiteNot Yet Recruiting
Hà Nội, Vietnam
Research SiteNot Yet Recruiting
Ho Chi Minh City, Vietnam
Research SiteNot Yet Recruiting
Hochiminh City, Vietnam
Research SiteWithdrawn
Viet Tri, Vietnam