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 (Eluminate-1)
August 28, 2026 updated by: AstraZeneca
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)
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 medication.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Buenos Aires, Argentina, C1425AGC
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CABA, Argentina, C1120AAC
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Caba, Argentina, C1128AAF
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Ciudad de Buenos Aires, Argentina, C1094AAD
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Mar del Plata, Argentina, B7600GNY
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San Nicolás, Argentina, B2900DMH
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San Vicente, Argentina, 5006
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Santa Fe, Argentina, S3000FWO
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Baotou, China, 014030
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Binzhou, China, 256606
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Cangzhou, China, 061002
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Changsha, China, 430033
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Chengdu, China, 610081
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Ganzhou, China, 341099
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Haikou, China, 570208
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Hangzhou, China, 310006
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Huangshi, China, 435000
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Huzhou, China, 313003
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Jinan, China, 250013
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Jinzhou, China, 121002
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Lanzhou, China, 730000
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Lianyungang, China, 222023
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Liaocheng, China, 252000
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Liuzhou, China, 545006
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Loudi, China, 417099
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Luoyang, China, 471003
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Luoyang, China, 471001
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Nanchang, China, 330006
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Nanjing, China, 2100008
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Nanjing, China, 211100
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Nanyang, China, 473000
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Ningbo, China, 315010
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Panjin, China, 124000
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Qingdao, China, 266035
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Sanmenxia, China, 472000
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Shanghai, China, 200040
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Suining Shi, China, 629000
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Tonghua, China, 134000
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Xi'an, China, 710077
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Xiangtan, China, 411100
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Xuancheng, China, 242000
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Yibin, China, 610500
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Yichang, China, 443003
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Yuncheng, China, 044099
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Zhengzhou, China, 450002
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Zhengzhou, China, 450012
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Zhenjiang, China, 212002
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Gandrup, Denmark, 9362
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Herlev, Denmark, 2730
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Hillerød, Denmark, 3400
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Hvidovre, Denmark, 2650
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Athens, Greece, 11526
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Athens, Greece, 10676
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Athens, Greece, 15125
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Athens, Greece, 12131
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Heraklion, Greece, 71500
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Piraeus, Greece, 18454
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Thessaloniki, Greece, 57010
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Thessaloniki, Greece, 57001
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Thessaloniki, Greece, 54636
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Budapest, Hungary, 1027
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Budapest, Hungary, 1138
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Budapest, Hungary, 1036
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Debrecen, Hungary, 4032
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Dunaújváros, Hungary, 2400
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Szeged, Hungary, 6725
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Szolnok, Hungary, 5000
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Amagasaki-shi, Japan, 660-8550
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Chiba, Japan, 261-0004
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Chitose-shi, Japan, 066-0032
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Chūōku, Japan, 1040031
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Koga-shi, Japan, 306-0232
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Minatoku, Japan, 105-0004
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Okayama, Japan, 701-1192
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Oyama-shi, Japan, 323-0022
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Shinjuku-ku, Japan, 169-0072
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Zentsuji-shi, Japan, 765-0071
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Bratislava, Slovakia, 81108
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Bratislava, Slovakia, 831 03
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Košice, Slovakia, 04001
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Martin, Slovakia, 036 01
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Námestovo, Slovakia, 02901
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Poprad, Slovakia, 05845
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Rožňava, Slovakia, 048 01
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Brackenfell, South Africa, 7560
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Cape Town, South Africa, 7570
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Cape Town, South Africa, 7500
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Claremont, South Africa, 7708
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Durban, South Africa, 4093
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Johannesburg, South Africa, 1827
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KwaDukuza, South Africa, 4449
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Paarl, South Africa, 7646
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Pretoria, South Africa, 2
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eMkhomazi, South Africa, 4170
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Jongno-gu, South Korea, 110-746
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Seongnam-si, South Korea, 463-712
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Seoul, South Korea, 03080
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Seoul, South Korea, 5505
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Barcelona, Spain, 08035
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Barcelona, Spain, 08016
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Barcelona, Spain, 08020
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Barcelona, Spain, 08930
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Figueres, Spain, 17600
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Seville, Spain, 41003
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Seville, Spain, 41950
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Changhua, Taiwan, 500
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Kaohsiung City, Taiwan, 80756
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Kaohsiung City, Taiwan, 813
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New Taipei City, Taiwan, 220
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Taichung, Taiwan, 40201
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 433004
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Tainan, Taiwan, 70403
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Tainan County, Taiwan, 71044
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Taipei, Taiwan, 10002
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Adana, Turkey (Türkiye), 01060
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Ankara, Turkey (Türkiye), 06530
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Ankara, Turkey (Türkiye), 06560
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Bursa, Turkey (Türkiye), 16310
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Izmir, Turkey (Türkiye), 35340
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Kayseri, Turkey (Türkiye), 38039
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Samsun, Turkey (Türkiye), 55139
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Alabama
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Birmingham, Alabama, United States, 35233
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Daphne, Alabama, United States, 36526
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California
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Lomita, California, United States, 90717
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Los Alamitos, California, United States, 90720
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San Diego, California, United States, 92111
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Walnut Creek, California, United States, 94598
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Colorado
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Englewood, Colorado, United States, 80110
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Florida
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Jacksonville, Florida, United States, 32256
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Orlando, Florida, United States, 32801
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Georgia
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Conyers, Georgia, United States, 30094
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Decatur, Georgia, United States, 30030
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Hinesville, Georgia, United States, 31313
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Kansas
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El Dorado, Kansas, United States, 67042
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Newton, Kansas, United States, 67114
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Kentucky
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Lexington, Kentucky, United States, 40509
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Louisiana
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Covington, Louisiana, United States, 70433
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Maryland
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Bowie, Maryland, United States, 20715
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Michigan
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Southfield, Michigan, United States, 48075
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Missouri
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Kansas City, Missouri, United States, 64111
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St Louis, Missouri, United States, 63141
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Nevada
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Las Vegas, Nevada, United States, 89119
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South Carolina
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Anderson, South Carolina, United States, 29621
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Tennessee
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Knoxville, Tennessee, United States, 37909
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Texas
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Fort Worth, Texas, United States, 76135
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Irving, Texas, United States, 75061
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Washington
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Renton, Washington, United States, 98057
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Elecoglipron dose level 1 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
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Elecoglipron is administered orally once daily.
A placebo matching dapagliflozin, administered orally once daily.
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Experimental: Elecoglipron dose level 2 + dapagliflozin-matched placebo
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
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Elecoglipron is administered orally once daily.
A placebo matching dapagliflozin, administered orally once daily.
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Experimental: Elecoglipron (one of the studied dose levels) + dapagliflozin
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
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Elecoglipron is administered orally once daily.
Dapagliflozin administered orally once daily.
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Placebo Comparator: Elecoglipron-matched placebo + dapagliflozin-matched placebo
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
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A placebo matching dapagliflozin, administered orally once daily.
A placebo matching elecoglipron, administered orally once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change from baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Achievement of HbA1c < 7% (53 mmol/mol)
Time Frame: Week 40
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Week 40
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Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Time Frame: Week 40
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Week 40
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Percent change in body weight
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in body weight
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Time to initiation of rescue medication over 40 weeks
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Change from baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Achievement of ≥5% weight loss from baseline
Time Frame: Baseline to Week 40
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Baseline to Week 40
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2026
Primary Completion (Estimated)
July 14, 2028
Study Completion (Estimated)
July 14, 2028
Study Registration Dates
First Submitted
June 18, 2026
First Submitted That Met QC Criteria
June 18, 2026
First Posted (Actual)
June 23, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7261C00002
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523936-37-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.