Type 2 Diabetes MellitusPhase 3Eluminate-4NCT07662135

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 Phase 3 study testing Elecoglipron in people with Type 2 Diabetes Mellitus and Type 2 Diabetes With Chronic Kidney Disease, run by AstraZeneca at 186 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease
What is being tested?: Elecoglipron
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 900 participants
Where: 186 sitesin 16 countries
Study dates: 6 Jul 2026to 13 Jul 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

186 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

186 sites in 16 countries

United States33 sites, 30 recruiting

Research Site
Albuquerque, New Mexico, 87102
Recruiting
Research Site
Arlington, Virginia, 22205
Suspended
Research Site
Braintree, Massachusetts, 02184
Not yet recruiting
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Chicago, Illinois, 60640
Not yet recruiting
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Cincinnati, Ohio, 45219
Not yet recruiting
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Concord, California, 94520
Not yet recruiting
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East Providence, Rhode Island, 02914
Not yet recruiting
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Fleming Island, Florida, 32003
Not yet recruiting
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Gaffney, South Carolina, 29340
Recruiting
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Greenville, South Carolina, 29605
Not yet recruiting
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Kansas City, Missouri, 64112
Recruiting
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Kinston, North Carolina, 28504
Not yet recruiting
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Las Vegas, Nevada, 89119
Not yet recruiting
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Lauderdale Lakes, Florida, 33313
Not yet recruiting
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Leesburg, Florida, 34748
Not yet recruiting
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Miami Lakes, Florida, 33016
Recruiting
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New Bedford, Massachusetts, 02740
Not yet recruiting
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Ocoee, Florida, 34761
Recruiting
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Ogden, Utah, 84405
Not yet recruiting
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Omaha, Nebraska, 68144
Not yet recruiting
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Orlando, Florida, 32804
Not yet recruiting
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Raleigh, North Carolina, 27609
Recruiting
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Sacramento, California, 95821
Recruiting
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Saint Joseph, Michigan, 49085
Suspended
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Saint Paul, Minnesota, 55117
Not yet recruiting
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San Antonio, Texas, 78212
Suspended
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San Antonio, Texas, 78257
Not yet recruiting
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Sun City, Arizona, 85373
Not yet recruiting
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Surprise, Arizona, 85374
Not yet recruiting
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The Bronx, New York, 10451
Not yet recruiting
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Victorville, California, 92392
Not yet recruiting
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Winston-Salem, North Carolina, 27103
Not yet recruiting
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Worcester, Massachusetts, 01604
Not yet recruiting

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Germany18 sites, 15 recruiting

Research Site
Bad Oeynhausen, 32545
Not yet recruiting
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Berlin, 12047
Not yet recruiting
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Brandenburg an der Havel, 14776
Withdrawn
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Chemnitz, 09116
Not yet recruiting
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Duisburg, 47051
Not yet recruiting
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Duisburg, 47269
Not yet recruiting
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Erlangen, 91054
Not yet recruiting
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Frankfurt, 60596
Not yet recruiting
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Hamburg, 22607
Not yet recruiting
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Heilbronn, 74076
Not yet recruiting
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Hohenmölsen, 06679
Not yet recruiting
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Ludwigshafen, 67059
Not yet recruiting
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Münster, 48153
Suspended
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Nittendorf, 93152
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Obertshausen, 63179
Not yet recruiting
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Pirna, 01796
Not yet recruiting
Research Site
Sankt Ingbert, 66386
Suspended
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Stuttgart, 70174
Not yet recruiting

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Japan16 sites, 16 recruiting

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Chigasaki-shi, 253-0044
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Chikushino-shi, 8188502
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Gifu, 501-1194
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Kagoshima, 892-0853
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Kitakyushu, 805-8508
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Kumamoto, 862-0965
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Kyoto, 605-0981
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Kyoto, 606-8507
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Maebashi, 371-8511
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Nagoya, 451-8511
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Nagoya, 468-0009
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Osaka, 559-0012
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Sapporo, 060-0062
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Suita-shi, 564-8565
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Tachikawa-shi, 190-8531
Not yet recruiting
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Toyota-Shi, 471-8513
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China15 sites, 15 recruiting

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Binzhou, 256606
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Changsha, 430033
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Chengdu, 610081
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Hangzhou, 310006
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Jinan, 250013
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Liaocheng, 252000
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Liuzhou, 545006
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Luoyang, 471003
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Nanjing, 211100
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Nanyang, 473000
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Suining Shi, 629000
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Yibin, 610500
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Yichang, 443003
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Zhengzhou, 450002
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Zhengzhou, 450012
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India13 sites, 13 recruiting

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Aligarh, 202002
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Belagavi, 590006
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Belgavi, 590010
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Calicut, 673 008
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Chennai, 600037
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Chennai, 600086
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Coimbatore, 641018
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Delhi, 110029
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Guntur, 522001
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Kolkata, 700020
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Lucknow, 226030
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Nagpur, 440010
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Pune, 411021
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Spain12 sites, 12 recruiting

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Barcelona, 08035
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Ferrol, 15405
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Lleida, 25198
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Madrid, 28040
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Majadahonda, 28222
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Málaga, 29010
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Santander, 39008
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Seville, 41010
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Seville, 41013
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Seville, 41950
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Valencia, 46010
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Zaragoza, 50009
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Taiwan11 sites, 11 recruiting

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Kaohsiung City, 833401
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New Taipei City, 23561
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New Taipei City
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Taichung, 40447
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Taichung, 40705
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Taichung, 433004
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Tainan, 710
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Taipei, 100
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Taoyuan, 333
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Guadalajara, 44150
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Guadalajara, 44600
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Mexico City, 0 3100
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Ukraine10 sites, 10 recruiting

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Kyiv, 01601
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Kyiv, 02002
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Kyiv, 03049
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Kyiv, 03057
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Kyiv, 04050
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Lviv, 79010
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Lviv, 79016
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Bulgaria9 sites, 9 recruiting

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Pleven, 5801
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Plovdiv, 4002
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Rousse, 7000
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Stara Zagora, 6001
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Varna, 9000
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Varna, 9020
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Turkey (Türkiye)8 sites, 8 recruiting

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Bakırköy, 34147
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Gaziantep, 27470
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Kayseri, 38080
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Yüreğir, 1240
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United Kingdom7 sites, 7 recruiting

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Hull, HU3 2JZ
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Penzance, TR18 3DX
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Sandbach, CW11 1EQ
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Thetford, IP24 1JD
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Vietnam7 sites, 6 recruiting

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Viet Tri, 35000
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Denmark6 sites, 6 recruiting

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Thailand6 sites, 6 recruiting

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Hat Yai, 90110
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Malaysia5 sites, 5 recruiting

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Miri, 98000
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Seremban, 70300
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Seri Manjung, 32040
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About this study

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)

Conditions: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease
Being tested: Elecoglipron, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElecoglipronDrug
Elecoglipron is administered orally once daily.
PlaceboDrug
Placebo is administered orally once daily.

Study groups in NCT07662135
Study group	Role	What they receive
Elecoglipron dose level 1	Experimental	Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg. Receives: Drug: Elecoglipron
Elecoglipron dose level 2	Experimental	Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg. Receives: Drug: Elecoglipron
Placebo	Placebo comparator	Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline to Week 40

Secondary outcomes (9)

Achievement of HbA1c < 7% (53 mmol/mol)
Measured: Week 40
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Measured: Week 40
Percent change in body weight
Measured: Baseline to Week 40
Change from baseline in body weight
Measured: Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
Measured: Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia)
Measured: Baseline to Week 40
Change from baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
Measured: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202613 Jul 2028

First posted23 Jun 2026
Study start6 Jul 2026
Primary completion13 Jul 2028 (estimated)
Study completion13 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 900 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07662135
Sponsor's protocol ID: D7261C00004
Other IDs: 2025-523940-12-00, 2025
Acronym: Eluminate-4
Status last verified: Sep 2026
First submitted: 18 Jun 2026
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07662135
Acronym / sponsor ID: Eluminate-4 / D7261C00004
Conditions: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 900 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Jul 2026 (actual)
Primary completion: 13 Jul 2028 (estimated)
Study completion: 13 Jul 2028 (estimated)
First posted: 23 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Elecoglipron dose level 1	Experimental	Drug: ElecoglipronParticipants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.
Elecoglipron dose level 2	Experimental	Drug: ElecoglipronParticipants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Impaired renal function
Body mass index (BMI) of ≥ 23 kg/m2 at screening

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElecoglipronElecoglipron is administered orally once daily.	Drug	Elecoglipron dose level 1, Elecoglipron dose level 2
PlaceboPlacebo is administered orally once daily.	Drug	Placebo

Primary outcome

Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 40

9 secondary outcomes

Achievement of HbA1c < 7% (53 mmol/mol)
Time frame: Week 40
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Time frame: Week 40
Percent change in body weight
Time frame: Baseline to Week 40
Change from baseline in body weight
Time frame: Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia)
Time frame: Baseline to Week 40
Change from baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
Time frame: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 40

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for Type 2 Diabetes Mellitus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

186 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elecoglipron in people with Type 2 Diabetes Mellitus and Type 2 Diabetes With Chronic Kidney Disease, run by AstraZeneca at 186 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, Germany, Japan, China, India and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.