Type 2 Diabetes MellitusPhase 3Eluminate-5NCT07662109
A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin 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 303 sites in 24 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other… 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
- 2,000 participants
- Where
- 303 sitesin 24 countries
- Study dates
- 6 Jul 2026to 5 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
303 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
303 sites in 24 countries
China48 sites, 47 recruiting
- Not yet recruiting
Research Site
Baotou
- Recruiting
Research Site
Beijing, 100044
- Not yet recruiting
Research Site
Beijing, 100050
- Not yet recruiting
Research Site
Beijing, 102218
- Not yet recruiting
Research Site
Changde, 415000
- Recruiting
Research Site
Changsha, 410015
- Not yet recruiting
Research Site
Changzhou, 272100
- Not yet recruiting
Research Site
Chengdu, 610078
- Recruiting
Research Site
Chengdu, 611130
- Not yet recruiting
Research Site
Chenzhou, 423000
- Not yet recruiting
Research Site
Chifeng, 024000
- Not yet recruiting
Research Site
Hangzhou, 310014
- Recruiting
Research Site
Hefei, 230601
- Recruiting
Research Site
Huai'an, 223005
- Recruiting
Research Site
Jinan, 250031
- Recruiting
Research Site
Jincheng, 048000
- Not yet recruiting
Research Site
Jining, 272006
- Recruiting
Research Site
Jinzhou Shi, 121001
- Recruiting
Research Site
Kaifeng, 475000
- Not yet recruiting
Research Site
Langfang, 065000
- Not yet recruiting
Research Site
Liangyugang, 222002
- Not yet recruiting
Research Site
Luoyang, 471009
- Not yet recruiting
Research Site
Meihekou, 135022
- Not yet recruiting
Research Site
Nanjing, 210011
- Not yet recruiting
Research Site
Nantong, 226001
- Recruiting
Research Site
Nanyang, 473009
- Recruiting
Research Site
Pinggu, 101200
- Not yet recruiting
Research Site
Pingxiang, 337055
- Withdrawn
Research Site
Sanya, 572000
- Not yet recruiting
Research Site
Shanghai, 200062
- Not yet recruiting
Research Site
Shanghai, 201199
- Not yet recruiting
Research Site
Shantou, 515065
- Not yet recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenyang, 110023
- Not yet recruiting
Research Site
Shijiazhuang, 050000
- Not yet recruiting
Research Site
Shijiazhuang, 050001
- Not yet recruiting
Research Site
Tianjin, 300000
- Not yet recruiting
Research Site
Wuhan, 430010
- Recruiting
Research Site
Wuhu, 241004
- Not yet recruiting
Research Site
Xi'an, 710077
- Not yet recruiting
Research Site
Xiangyang, 441000
- Not yet recruiting
Research Site
Xianyang, 712000
- Not yet recruiting
Research Site
Xuzhou, 221000
- Not yet recruiting
Research Site
Xuzhou, 221009
- Not yet recruiting
Research Site
Yan’an, 716000
- Not yet recruiting
Research Site
Yueyang, 414000
- Recruiting
Research Site
Zhumadian, 463000
- Not yet recruiting
Research Site
Zibo, 255499
United States45 sites, 43 recruiting
- Recruiting
Research Site
Albuquerque, New Mexico, 87112
- Not yet recruiting
Research Site
Annapolis, Maryland, 21401
- Not yet recruiting
Research Site
Atlanta, Georgia, 30315
- Not yet recruiting
Research Site
Bakersfield, California, 93309
- Not yet recruiting
Research Site
Beachwood, Ohio, 44122
- Not yet recruiting
Research Site
Boston, Massachusetts, 02114
- Not yet recruiting
Research Site
Boston, Massachusetts, 02115
- Recruiting
Research Site
Brooklyn, New York, 11201
- Recruiting
Research Site
Chicago, Illinois, 60640
- Recruiting
Research Site
Dallas, Texas, 75230
- Not yet recruiting
Research Site
Elkhorn, Nebraska, 68022
- Not yet recruiting
Research Site
Evansville, Indiana, 47714
- Not yet recruiting
Research Site
Huntsville, Alabama, 35801
- Recruiting
Research Site
Kingsport, Tennessee, 37660
- Recruiting
Research Site
Kingwood, West Virginia, 26537
- Recruiting
Research Site
Lake City, Florida, 32055
- Recruiting
Research Site
Lakeland, Florida, 33813
- Not yet recruiting
Research Site
Layton, Utah, 84041
- Recruiting
Research Site
Little Rock, Arkansas, 72205
- Recruiting
Research Site
Los Angeles, California, 90017
- Not yet recruiting
Research Site
Lutherville-Timonium, Maryland, 21093
- Recruiting
Research Site
Maumee, Ohio, 43537
- Not yet recruiting
Research Site
McKinney, Texas, 75069
- Not yet recruiting
Research Site
Mobile, Alabama, 36608
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
Newport News, Virginia, 23606
- Not yet recruiting
Research Site
Norman, Oklahoma, 73069
- Not yet recruiting
Research Site
Ontario, California, 91762
- Recruiting
Research Site
Oxon Hill, Maryland, 20745
- Recruiting
Research Site
Paris, Texas, 75462
- Not yet recruiting
Research Site
Philadelphia, Pennsylvania, 19114
- Not yet recruiting
Research Site
Raleigh, North Carolina, 27607
- Not yet recruiting
Research Site
Redmond, Washington, 98052
- Recruiting
Research Site
Ridgeland, Mississippi, 39157
- Not yet recruiting
Research Site
Rosedale, New York, 11422
- Not yet recruiting
Research Site
San Antonio, Texas, 78258
- Not yet recruiting
Research Site
Sheffield, Alabama, 35660
- Not yet recruiting
Research Site
Sioux City, Iowa, 51106
- Not yet recruiting
Research Site
Skokie, Illinois, 60077
- Withdrawn
Research Site
South Jordan, Utah, 84095
- Not yet recruiting
Research Site
Toms River, New Jersey, 08755
- Recruiting
Research Site
Troy, Michigan, 48098
- Not yet recruiting
Research Site
Vienna, Virginia, 22182
- Withdrawn
Research Site
Webster, Texas, 77598
- Not yet recruiting
Research Site
Zachary, Louisiana, 70791
India17 sites, 17 recruiting
- Not yet recruiting
Research Site
Bangalore, 560 092
- Not yet recruiting
Research Site
Belagavi, 590006
- Not yet recruiting
Research Site
Belagavi, 590010
- Not yet recruiting
Research Site
Calicut, 673008
- Not yet recruiting
Research Site
Chennai, 600086
- Not yet recruiting
Research Site
Coimbatore, 641018
- Not yet recruiting
Research Site
Guwahati, 781032
- Not yet recruiting
Research Site
Indore, 452008
- Not yet recruiting
Research Site
Jaipur, 302017
- Not yet recruiting
Research Site
Kochi, 682040
- Not yet recruiting
Research Site
Kochi, 682041
- Not yet recruiting
Research Site
Lucknow, 226030
- Not yet recruiting
Research Site
Madurai, 625020
- Not yet recruiting
Research Site
Mumbai, 400012
- Not yet recruiting
Research Site
Nagpur, 440010
- Not yet recruiting
Research Site
New Delhi, 11029
- Not yet recruiting
Research Site
Thiruvananthapuram, 695031
Germany16 sites, 14 recruiting
- Recruiting
Research Site
Berlin, 13597
- Not yet recruiting
Research Site
Cologne, 51069
- Not yet recruiting
Research Site
Damme, 49401
- Not yet recruiting
Research Site
Deggingen, 73326
- Not yet recruiting
Research Site
Duisburg, 47269
- Recruiting
Research Site
Essen, 45355
- Suspended
Research Site
Falkensee, 14612
- Recruiting
Research Site
Frankfurt, 60596
- Recruiting
Research Site
Hamburg, 22607
- Recruiting
Research Site
Leipzig, 04249
- Recruiting
Research Site
Münster, 48145
- Recruiting
Research Site
Nittendorf, 93152
- Recruiting
Research Site
Pohlheim, 35415
- Withdrawn
Research Site
Villingen-Schwenningen, 78048
- Not yet recruiting
Research Site
Wallerfing, 94574
- Recruiting
Research Site
Weinheim, 69469
Japan16 sites, 15 recruiting
- Recruiting
Research Site
Chūōku, 103-0027
- Not yet recruiting
Research Site
Fukuoka, 813-0044
- Recruiting
Research Site
Hachioji-shi, 192-0083
- Recruiting
Research Site
Ichikawa-shi, 272-8516
- Not yet recruiting
Research Site
Kamakura-shi, 247-0055
- Not yet recruiting
Research Site
Kamakura-shi, 247-0056
- Recruiting
Research Site
Kishiwada-shi, 596-8501
- Not yet recruiting
Research Site
Kitakyushu, 805-8508
- Recruiting
Research Site
Meguro-ku, 153-0053
- Not yet recruiting
Research Site
Mito, 310-0826
- Recruiting
Research Site
Sapporo, 060-0061
- Recruiting
Research Site
Shinjuku-ku, 160-0008
- Not yet recruiting
Research Site
Soka-shi, 340-0015
- Withdrawn
Research Site
Tama-shi, 206-0033
- Recruiting
Research Site
Yamato-shi, 242-0004
- Not yet recruiting
Research Site
Yokohama, 232-0064
South Korea12 sites, 12 recruiting
- Not yet recruiting
Research Site
Busan, 49241
- Recruiting
Research Site
Goyang-si, 411-706
- Recruiting
Research Site
Guri-si, 11923
- Recruiting
Research Site
Gwangju, 61453
- Recruiting
Research Site
Gyeonggi-do, 13620
- Not yet recruiting
Research Site
Seoul, 01830
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06273
- Not yet recruiting
Research Site
Seoul, 07345
- Not yet recruiting
Research Site
Seoul, 136-705
- Not yet recruiting
Research Site
Suwon, 16499
- Recruiting
Research Site
Yangsan, 50612
Taiwan12 sites, 12 recruiting
- Recruiting
Research Site
Changhua, 500
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Kaohsiung City, 813
- Recruiting
Research Site
New Taipei City, 220
- Not yet recruiting
Research Site
New Taipei City, 24352
- Recruiting
Research Site
Taichung, 40201
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taichung, 433004
- Recruiting
Research Site
Tainan, 70403
- Recruiting
Research Site
Tainan County, 71044
- Recruiting
Research Site
Taipei, 10002
- Not yet recruiting
Research Site
Taoyuan, 333
Brazil11 sites, 11 recruiting
- Not yet recruiting
Research Site
Barretos, 14784-400
- Not yet recruiting
Research Site
Brasília, 71625-009
- Not yet recruiting
Research Site
Campinas, 13060-803
- Not yet recruiting
Research Site
Curitiba, 80030-480
- Not yet recruiting
Research Site
Fortaleza, 60426-000
- Recruiting
Research Site
Natal, 59020-500
- Not yet recruiting
Research Site
Porto Alegre, 90630-165
- Not yet recruiting
Research Site
Rio de Janeiro, 22270-060
- Not yet recruiting
Research Site
São José dos Campos, 12243-280
- Not yet recruiting
Research Site
São Paulo, 01228-200
- Not yet recruiting
Research Site
São Paulo, 04012-180
South Africa11 sites, 11 recruiting
- Recruiting
Research Site
Brackenfell, 7560
- Not yet recruiting
Research Site
Cape Town, 7500
- Recruiting
Research Site
Cape Town, 7570
- Recruiting
Research Site
Claremont, 7708
- Recruiting
Research Site
Durban, 4091
- Not yet recruiting
Research Site
Durban, 4093
- Recruiting
Research Site
eMkhomazi, 4170
- Not yet recruiting
Research Site
Johannesburg, 1827
- Not yet recruiting
Research Site
KwaDukuza, 4449
- Not yet recruiting
Research Site
Paarl, 7646
- Not yet recruiting
Research Site
Pretoria, 0083
Ukraine11 sites, 10 recruiting
- Not yet recruiting
Research Site
Kyiv, 02002
- Not yet recruiting
Research Site
Kyiv, 03037
- Not yet recruiting
Research Site
Kyiv, 03049
- Not yet recruiting
Research Site
Kyiv, 03057
- Not yet recruiting
Research Site
Kyiv, 04114
- Not yet recruiting
Research Site
Kyiv, 04210
- Recruiting
Research Site
Lviv, 79010
- Recruiting
Research Site
Lviv, 79016
- Recruiting
Research Site
Uzhhorod, 88002
- Withdrawn
Research Site
Uzhhorod, 88014
- Recruiting
Research Site
Vinnytsia, 21001
United Kingdom10 sites, 10 recruiting
- Not yet recruiting
Research Site
Blackburn, BB2 1AX
- Recruiting
Research Site
Dundee, DD1 9SY
- Recruiting
Research Site
Guisborough, TS14 7DJ
- Not yet recruiting
Research Site
Nantwich, CW5 5NX
- Not yet recruiting
Research Site
Rotherham, S65 1DA
- Recruiting
Research Site
Thetford, IP24 1JD
- Recruiting
Research Site
Weston-super-Mare, BS24 7PR
- Recruiting
Research Site
Witney, OX28 6JS
- Not yet recruiting
Research Site
Woodbridge, IP136TH
- Recruiting
Research Site
Yate, BS37 4AX
Argentina9 sites, 9 recruiting
- Not yet recruiting
Research Site
Buenos Aires, C1012AAR
- Recruiting
Research Site
Buenos Aires, C1120AAC
- Not yet recruiting
Research Site
Buenos Aires, C1425AGC
- Not yet recruiting
Research Site
Caba, C1128AAF
- Not yet recruiting
Research Site
Ciudad de Buenos Aires, C1094AAD
- Not yet recruiting
Research Site
Mar del Plata, B7600GNY
- Not yet recruiting
Research Site
Rosario, S2000CVD
- Not yet recruiting
Research Site
San Nicolás, B2900DMH
- Not yet recruiting
Research Site
San Vicente, 5006
Poland9 sites, 9 recruiting
- Recruiting
Research Site
Bialystok, 15-897
- Recruiting
Research Site
Częstochowa, 42-217
- Recruiting
Research Site
Kielce, 25-355
- Recruiting
Research Site
Lodz, 90-338
- Not yet recruiting
Research Site
Lublin, 20-718
- Recruiting
Research Site
Poznan, 60-354
- Recruiting
Research Site
Radom, 26-600
- Recruiting
Research Site
Warsaw, 00-124
- Recruiting
Research Site
Warsaw, 02-507
Czechia8 sites, 8 recruiting
- Recruiting
Research Site
Hradec Králové, 500 02
- Recruiting
Research Site
Humpolec, 396 01
- Not yet recruiting
Research Site
Jílové u Prahy, 254 01
- Not yet recruiting
Research Site
Ostrava, 702 00
- Not yet recruiting
Research Site
Prague, 147 00
- Recruiting
Research Site
Prague, 149 00
- Not yet recruiting
Research Site
Prague, 160 00
- Not yet recruiting
Research Site
Příbram, 261 01
Greece8 sites, 8 recruiting
- Not yet recruiting
Research Site
Alexandroupoli, 68100
- Recruiting
Research Site
Athens, 115 25
- Not yet recruiting
Research Site
Athens, 11527
- Recruiting
Research Site
Athens, 17562
- Recruiting
Research Site
Ioannina, 45110
- Recruiting
Research Site
Thessaloniki, 54635
- Recruiting
Research Site
Thessaloniki, 54642
- Recruiting
Research Site
Thessaloniki, 54645
Mexico8 sites, 8 recruiting
- Not yet recruiting
Research Site
Cuernavaca, 62250
- Not yet recruiting
Research Site
Cuernavaca, 62448
- Not yet recruiting
Research Site
Guadalajara, 44600
- Not yet recruiting
Research Site
Guadalajara, 44650
- Not yet recruiting
Research Site
Guadalajara, 44670
- Not yet recruiting
Research Site
Monterrey, 64460
- Not yet recruiting
Research Site
San Luis Potosí City, 78200
- Not yet recruiting
Research Site
Zapopan, 45116
Slovakia8 sites, 8 recruiting
- Not yet recruiting
Research Site
Bojnice, 97201
- Recruiting
Research Site
Bratislava, 81108
- Not yet recruiting
Research Site
Lučenec, 984 01
- Recruiting
Research Site
Námestovo, 029 01
- Not yet recruiting
Research Site
Rožňava, 048 01
- Not yet recruiting
Research Site
Trebišov, 075 01
- Recruiting
Research Site
Vrútky, 038 61
- Not yet recruiting
Research Site
Žilina, 010 01
Thailand8 sites, 8 recruiting
- Not yet recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Banphaeo, 74120
- Not yet recruiting
Research Site
Changwat Sara Buri, 18000
- Recruiting
Research Site
Khlong Luang, 12120
- Not yet recruiting
Research Site
Khon Kaen, 40002
- Not yet recruiting
Research Site
Muang, 70000
- Recruiting
Research Site
Mueang, 20000
- Not yet recruiting
Research Site
Ratchathewi, 10400
Denmark7 sites, 7 recruiting
- Not yet recruiting
Research Site
Aarhus N, 8200
- Recruiting
Research Site
Esbjerg, 6700
- Recruiting
Research Site
Gandrup, 9362
- Recruiting
Research Site
Herlev, 2730
- Recruiting
Research Site
Hillerød, 3400
- Not yet recruiting
Research Site
Hvidovre, 2650
- Recruiting
Research Site
Odense, 5000
Hungary7 sites, 6 recruiting
- Not yet recruiting
Research Site
Budapest, 1036
- Suspended
Research Site
Budapest, 1089
- Not yet recruiting
Research Site
Debrecen, 4032
- Not yet recruiting
Research Site
Salgótarján, 3100
- Not yet recruiting
Research Site
Szeged, 6725
- Not yet recruiting
Research Site
Szolnok, 5000
- Not yet recruiting
Research Site
Zalaegerszeg, 8900
Malaysia7 sites, 6 recruiting
- Recruiting
Research Site
Alor Star, 05400
- Withdrawn
Research Site
Ipoh, 30450
- Recruiting
Research Site
Kangar, 01000
- Recruiting
Research Site
Kuala Lumpur, 59100
- Recruiting
Research Site
Sarawak Miri, 98000
- Recruiting
Research Site
Seremban, 70300
- Recruiting
Research Site
Seri Manjung, 32040
Turkey (Türkiye)7 sites, 7 recruiting
- Not yet recruiting
Research Site
Ankara, 06540
- Not yet recruiting
Research Site
Ankara, 6200
- Not yet recruiting
Research Site
Gaziantep, 27470
- Not yet recruiting
Research Site
Istanbul, 34010
- Not yet recruiting
Research Site
Istanbul, 34265
- Not yet recruiting
Research Site
Istanbul, 34384
- Not yet recruiting
Research Site
Konya, 42130
Vietnam7 sites, 7 recruiting
- Not yet recruiting
Research Site
Hanoi, 10000
- Not yet recruiting
Research Site
Hồ Chí Minh, 700000
- Not yet recruiting
Research Site
Ho Chi Minh City, 700000
- Not yet recruiting
Research Site
Hochiminh, 700000
- Not yet recruiting
Research Site
Hochiminh City, 700000
- Not yet recruiting
Research Site
Huế, 530000
- Not yet recruiting
Research Site
Rach Gia, 920000
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
Research Site
San Juan, 00918
About this study
Official title: A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
- 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 group | Role | What they receive |
|---|---|---|
| Elecoglipron dose level 1 + dapagliflozin | Experimental | Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily. Receives: Drug: Elecoglipron; Drug: Dapagliflozin |
| Elecoglipron dose level 2 + dapagliflozin | Experimental | Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily. Receives: Drug: Elecoglipron; Drug: Dapagliflozin |
| 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-matched placebo + dapagliflozin | Active comparator | Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily. Receives: Drug: Dapagliflozin; Drug: Elecoglipron-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 (10)
Change from baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline to Week 40
Achievement of HbA1c < 7% (53 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 Fasting Plasma Glucose (FPG)
Measured: Baseline to Week 40
Change from baseline in daily mean 7-point Self-Monitored Blood Glucose (SMBG)
Measured: Baseline to Week 40
Achievement of ≥ 5% weight loss from baseline
Measured: Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
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.
- First posted23 Jun 2026
- Study start6 Jul 2026
- Primary completion5 Jul 2028 (estimated)
- Study completion5 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662109
- Sponsor's protocol ID
- D7261C00003
- Other IDs
- 2025-523941-81-00, 2025
- Acronym
- Eluminate-5
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 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 and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
- ClinicalTrials.gov ID
- NCT07662109
- Acronym / sponsor ID
- Eluminate-5 / D7261C00003
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 5 Jul 2028 (estimated)
- Study completion
- 5 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.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Elecoglipron dose level 1 + dapagliflozin | Experimental | Drug: Elecoglipron, Drug: DapagliflozinParticipants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily. |
| Elecoglipron dose level 2 + dapagliflozin | Experimental | Drug: Elecoglipron, Drug: DapagliflozinParticipants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily. |
| 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-matched placebo + dapagliflozin | Active comparator | Drug: Dapagliflozin, Drug: Elecoglipron-matched placeboParticipants will receive elecoglipron-matched placebo + dapagliflozin, 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 dose level 1 + dapagliflozin, Elecoglipron dose level 1 + dapagliflozin-matched placebo, Elecoglipron dose level 2 + dapagliflozin, Elecoglipron dose level 2 + dapagliflozin-matched placebo |
| DapagliflozinDapagliflozin administered orally once daily. | Drug | Elecoglipron dose level 1 + dapagliflozin, Elecoglipron dose level 2 + dapagliflozin, Elecoglipron-matched placebo + dapagliflozin |
| Elecoglipron-matched placeboA placebo matching elecoglipron administered orally once daily. | Drug | Elecoglipron-matched placebo + dapagliflozin |
| 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 |
Primary outcome
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 40
10 secondary outcomes
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 40
Achievement of HbA1c < 7% (53 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 Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 40
Change from baseline in daily mean 7-point Self-Monitored Blood Glucose (SMBG)
Time frame: Baseline to Week 40
Achievement of ≥ 5% weight loss from baseline
Time frame: Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP)
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 30 Oct 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
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
303 sites in 24 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 303 sites in 24 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 303 sites in China, United States, India, Germany, Japan and 19 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. 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?
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 30 Oct 2026.