Type 2 Diabetes MellitusPhase 3Eluminate-1NCT07662044

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

A Phase 3 study testing Elecoglipron and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 149 sites in 13 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 alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Elecoglipron and Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 800 participants
Where: 149 sitesin 13 countries
Study dates: 6 Jul 2026to 14 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 (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
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

149 sites in 13 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

149 sites in 13 countries

China39 sites, 39 recruiting

Research Site
Baotou, 014030
Not yet recruiting
Research Site
Binzhou, 256606
Not yet recruiting
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Cangzhou, 061002
Not yet recruiting
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Changsha, 430033
Not yet recruiting
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Chengdu, 610081
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Ganzhou, 341099
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Haikou, 570208
Not yet recruiting
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Hangzhou, 310006
Not yet recruiting
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Huangshi, 435000
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Huzhou, 313003
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Jinan, 250013
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Jinzhou, 121002
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Lanzhou, 730000
Not yet recruiting
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Lianyungang, 222023
Not yet recruiting
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Liaocheng, 252000
Not yet recruiting
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Liuzhou, 545006
Not yet recruiting
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Loudi, 417099
Not yet recruiting
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Luoyang, 471001
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Luoyang, 471003
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Nanchang, 330006
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Nanjing, 2100008
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Nanjing, 211100
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Nanyang, 473000
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Ningbo, 315010
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Panjin, 124000
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Qingdao, 266035
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Sanmenxia, 472000
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Shanghai, 200040
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Suining Shi, 629000
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Tonghua, 134000
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Xi'an, 710077
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Xiangtan, 411100
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Xuancheng, 242000
Not yet recruiting
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Yibin, 610500
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Yichang, 443003
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Yuncheng, 044099
Not yet recruiting
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Zhengzhou, 450002
Not yet recruiting
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Zhengzhou, 450012
Not yet recruiting
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Zhenjiang, 212002
Not yet recruiting

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United States27 sites, 24 recruiting

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Anderson, South Carolina, 29621
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Birmingham, Alabama, 35233
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Bowie, Maryland, 20715
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Bridgeport, Connecticut, 06606
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Conyers, Georgia, 30094
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Covington, Louisiana, 70433
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Daphne, Alabama, 36526
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Decatur, Georgia, 30030
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El Dorado, Kansas, 67042
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Englewood, Colorado, 80110
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Fort Worth, Texas, 76135
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Hinesville, Georgia, 31313
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Irving, Texas, 75061
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Jacksonville, Florida, 32256
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37909
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Las Vegas, Nevada, 89119
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Lexington, Kentucky, 40509
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Lomita, California, 90717
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Los Alamitos, California, 90720
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Newton, Kansas, 67114
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Orlando, Florida, 32801
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Renton, Washington, 98057
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San Diego, California, 92111
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Southfield, Michigan, 48075
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St Louis, Missouri, 63141
Not yet recruiting
Research Site
Walnut Creek, California, 94598
Suspended

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Japan10 sites, 10 recruiting

Research Site
Amagasaki-shi, 660-8550
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Chiba, 261-0004
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Chitose-shi, 066-0032
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Chūōku, 1040031
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Koga-shi, 306-0232
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Minatoku, 105-0004
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Okayama, 701-1192
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Oyama-shi, 323-0022
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Shinjuku-ku, 169-0072
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Zentsuji-shi, 765-0071
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South Africa10 sites, 10 recruiting

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Cape Town, 7500
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Cape Town, 7570
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Claremont, 7708
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Durban, 4093
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eMkhomazi, 4170
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Johannesburg, 1827
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KwaDukuza, 4449
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Paarl, 7646
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Pretoria, 2
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Taiwan10 sites, 10 recruiting

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Changhua, 500
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Kaohsiung City, 80756
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Kaohsiung City, 813
Not yet recruiting
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New Taipei City, 220
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Taichung, 40201
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Taichung, 40705
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Taichung, 433004
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Tainan, 70403
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Tainan County, 71044
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Taipei, 10002
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Greece9 sites, 9 recruiting

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Athens, 11526
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Athens, 12131
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Athens, 15125
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Heraklion, 71500
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Piraeus, 18454
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Thessaloniki, 54636
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Thessaloniki, 57001
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San Nicolás, B2900DMH
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Debrecen, 4032
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Dunaújváros, 2400
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Szolnok, 5000
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Slovakia7 sites, 7 recruiting

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Košice, 04001
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Martin, 036 01
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Barcelona, 08020
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Barcelona, 08035
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Barcelona, 08930
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Figueres, 17600
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Seville, 41003
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Seville, 41950
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Turkey (Türkiye)7 sites, 7 recruiting

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Ankara, 06530
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Ankara, 06560
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Bursa, 16310
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Izmir, 35340
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Kayseri, 38039
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Samsun, 55139
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Denmark4 sites, 4 recruiting

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Hillerød, 3400
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Hvidovre, 2650
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South Korea4 sites, 4 recruiting

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Seongnam-si, 463-712
Not yet recruiting
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Seoul, 03080
Not yet recruiting
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Seoul, 5505
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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 Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)

Conditions: Type 2 Diabetes Mellitus
Being tested: Elecoglipron, Dapagliflozin, Elecoglipron-matched placebo, Dapagliflozin-matched 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.
DapagliflozinDrug
Dapagliflozin administered orally once daily.
Elecoglipron-matched placeboDrug
A placebo matching elecoglipron, administered orally once daily.
Dapagliflozin-matched placeboDrug
A placebo matching dapagliflozin, administered orally once daily.

Study groups in NCT07662044
Study group	Role	What they receive
Elecoglipron dose level 1 + dapagliflozin-matched placebo	Experimental	Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily. Receives: Drug: Elecoglipron; Drug: Dapagliflozin-matched placebo
Elecoglipron dose level 2 + dapagliflozin-matched placebo	Experimental	Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily. Receives: Drug: Elecoglipron; Drug: Dapagliflozin-matched placebo
Elecoglipron (one of the studied dose levels) + dapagliflozin	Experimental	Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily. Receives: Drug: Elecoglipron; Drug: Dapagliflozin
Elecoglipron-matched placebo + dapagliflozin-matched placebo	Placebo comparator	Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily. Receives: Drug: Elecoglipron-matched placebo; Drug: Dapagliflozin-matched 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 (8)

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 ≥5% weight loss from baseline
Measured: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
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 202614 Jul 2028

First posted23 Jun 2026
Study start6 Jul 2026
Primary completion14 Jul 2028 (estimated)
Study completion14 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: 800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07662044
Sponsor's protocol ID: D7261C00002
Other IDs: 2025-523936-37-00, 2025
Acronym: Eluminate-1
Status last verified: Aug 2026
First submitted: 18 Jun 2026
Last updated: 31 Aug 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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 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 Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
ClinicalTrials.gov ID: NCT07662044
Acronym / sponsor ID: Eluminate-1 / D7261C00002
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 800 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Jul 2026 (actual)
Primary completion: 14 Jul 2028 (estimated)
Study completion: 14 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: 4

Arm	Type	Receives
Elecoglipron dose level 1 + dapagliflozin-matched placebo	Experimental	Drug: Elecoglipron, Drug: Dapagliflozin-matched placeboParticipants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
Elecoglipron dose level 2 + dapagliflozin-matched placebo	Experimental	Drug: Elecoglipron, Drug: Dapagliflozin-matched placeboParticipants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
Elecoglipron (one of the studied dose levels) + dapagliflozin	Experimental	Drug: Elecoglipron, Drug: DapagliflozinParticipants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
Elecoglipron-matched placebo + dapagliflozin-matched placebo	Placebo comparator	Drug: Elecoglipron-matched placebo, Drug: Dapagliflozin-matched placeboParticipants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to 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 (one of the studied dose levels) + dapagliflozin, Elecoglipron dose level 1 + dapagliflozin-matched placebo, Elecoglipron dose level 2 + dapagliflozin-matched placebo
DapagliflozinDapagliflozin administered orally once daily.	Drug	Elecoglipron (one of the studied dose levels) + dapagliflozin
Elecoglipron-matched placeboA placebo matching elecoglipron, administered orally once daily.	Drug	Elecoglipron-matched placebo + dapagliflozin-matched placebo
Dapagliflozin-matched placeboA placebo matching dapagliflozin, administered orally once daily.	Drug	Elecoglipron dose level 1 + dapagliflozin-matched placebo, Elecoglipron dose level 2 + dapagliflozin-matched placebo, Elecoglipron-matched placebo + dapagliflozin-matched placebo

Primary outcome

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

8 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 ≥5% weight loss from baseline
Time frame: Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 40
Time to initiation of rescue medication over 40 weeks
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 31 Aug 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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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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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

149 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elecoglipron and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 149 sites in 13 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 5 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in China, United States, Japan, South Africa, Taiwan and 8 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 NCT07662044.

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 31 Aug 2026.