A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus (Eluminate-2)
September 7, 2026 updated by: AstraZeneca
A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1200
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
- Recruiting
- Research Site
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Buenos Aires, Argentina, C1120AAC
- Not yet recruiting
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Caba, Argentina, C1128AAF
- Not yet recruiting
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Ciudad de Buenos Aires, Argentina, C1094AAD
- Recruiting
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Rosario, Argentina, S2000CVD
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San Nicolás, Argentina, B2900DMH
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San Vicente, Argentina, 5006
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Botany, Australia, 2019
- Recruiting
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East Toowoomba, Australia, 4350
- Recruiting
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Fitzroy, Australia, 3065
- Not yet recruiting
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Heidelberg Heights, Australia, 3081
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Kingswood, Australia, 2747
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Melbourne, Australia, 3004
- Recruiting
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Parkville, Australia, 3050
- Recruiting
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Penrith, Australia, 2750
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St Leonards, Australia, 2065
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Brasília, Brazil, 71625-009
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Campinas, Brazil, 13060-803
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Curitiba, Brazil, 80030-480
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Natal, Brazil, 59020-500
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Porto Alegre, Brazil, 90630-165
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São José dos Campos, Brazil, 12243-280
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São Paulo, Brazil, 04012-180
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Plovdiv, Bulgaria, 4001
- Recruiting
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1618
- Recruiting
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Sofia, Bulgaria, 1700
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Yambol, Bulgaria, 8600
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
- Recruiting
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Ontario
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Guelph, Ontario, Canada, N1H 1B1
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Sarnia, Ontario, Canada, N7T 4X3
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Scarborough Village, Ontario, Canada, M1R 0B1
- Recruiting
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Stouffville, Ontario, Canada, L4A1H2
- Recruiting
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M6G 1M2
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Toronto, Ontario, Canada, M4G3E8
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Quebec
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Montreal, Quebec, Canada, H4N 2W2
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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
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Changsha, China, 410013
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Changsha, China, 410015
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Hefei, China, 230601
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Hefei, China, 230000
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Huai'an, China, 223005
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Langfang, China, 065000
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Liangyugang, China, 222002
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Luoyang, China, 471009
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Nanjing, China, 2100008
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Nanyang, China, 473009
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Pinggu, China, 101200
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Pingxiang, China, 337055
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Shijiazhuang, China, 050000
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Tianjin, China, 300134
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Yueyang, China, 414000
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Bad Oeynhausen, Germany, 32545
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Berlin, Germany, 13597
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Chemnitz, Germany, 09116
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Damme, Germany, 49401
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Duisburg, Germany, 47051
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Elsterwerda, Germany, 04910
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Erlangen, Germany, 91054
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Essen, Germany, 45359
- Withdrawn
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Falkensee, Germany, 14612
- Recruiting
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Gladbeck, Germany, 45968
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Hamburg, Germany, 22607
- Recruiting
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Hamburg, Germany, 21109
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Leipzig, Germany, 04249
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Mannheim, Germany, 68167
- Withdrawn
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Münster, Germany, 48145
- Recruiting
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Oldenburg, Germany, 23758
- Recruiting
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Pirna, Germany, 01796
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Sankt Ingbert, Germany, 66386
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Wangen, Germany, 88239
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Budapest, Hungary, 1036
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Budapest, Hungary, 1132
- Recruiting
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Budapest, Hungary, 1089
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Debrecen, Hungary, 4032
- Not yet recruiting
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Salgótarján, Hungary, 3100
- Withdrawn
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Szeged, Hungary, 6725
- Not yet recruiting
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Szolnok, Hungary, 5000
- Withdrawn
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Zalaegerszeg, Hungary, 8900
- Withdrawn
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Bari, Italy, 70124
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Bologna, Italy, 40138
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Chieti, Italy, 66100
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Milan, Italy, 20138
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Milan, Italy, 20132
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Modena, Italy, 41100
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Naples, Italy, 80138
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Roma, Italy, 00161
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Roma, Italy, 00168
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Asahikawa-shi, Japan, 070-8530
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Chūōku, Japan, 103-0002
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Kamakura-shi, Japan, 247-0056
- Recruiting
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Koga-shi, Japan, 306-0232
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Kumamoto, Japan, 862-0976
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Mitaka-shi, Japan, 181-0013
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Mito, Japan, 310-0826
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Miyazaki, Japan, 880-0034
- Recruiting
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Nagoya, Japan, 467-8602
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Nagoya, Japan, 468-0009
- Recruiting
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Naka, Japan, 311-0113
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Naka, Japan, 311-0133
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Nishinomiya-shi, Japan, 663-8113
- Recruiting
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Osaka, Japan, 558-8558
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Sapporo, Japan, 062-0007
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Takamatsu, Japan, 760-0018
- Recruiting
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Bialystok, Poland, 15-897
- Recruiting
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Krakow, Poland, 31-261
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Lodz, Poland, 90-338
- Recruiting
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Lublin, Poland, 20-718
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Poznan, Poland, 60-354
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Radom, Poland, 26-600
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Warsaw, Poland, 02-507
- Recruiting
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Warsaw, Poland, 00-124
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Busan, South Korea, 48108
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Changwon-si, South Korea, 51353
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Daegu, South Korea, 41404
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Daejeon, South Korea, 35015
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Daejeon, South Korea, 35233
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Guri-si, South Korea, 11923
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Incheon, South Korea, 21565
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Seoul, South Korea, 3722
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Seoul, South Korea, 06351
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Seoul, South Korea, 05278
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Changhua, Taiwan, 50006
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Kaohsiung City, Taiwan, 81362
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New Taipei City, Taiwan, 220
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Taichung, Taiwan, 40705
- Recruiting
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Taichung, Taiwan, 40201
- Recruiting
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Taichung, Taiwan, 433004
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taoyuan, Taiwan, 333
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Yung Kang City, Taiwan, 71044
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Aberdeen, United Kingdom, AB25 2ZN
- Recruiting
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Addlestone, United Kingdom, KT15 2BH
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Banbury, United Kingdom, OX16 9AD
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Bristol, United Kingdom, BS34 6BQ
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Bristol, United Kingdom, BS34 5TF
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Edinburgh, United Kingdom, EH4 2XU
- Recruiting
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Hounslow, United Kingdom, TW3 3LN
- Recruiting
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Penzance, United Kingdom, TR18 3DX
- Recruiting
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Poole, United Kingdom, BH16 5PW
- Recruiting
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Soham, United Kingdom, CB7 5JD
- Recruiting
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Wansford, United Kingdom, PE8 6PL
- Withdrawn
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Yate, United Kingdom, BS37 4AX
- Recruiting
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Alabama
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Birmingham, Alabama, United States, 35205
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Arizona
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Mesa, Arizona, United States, 85213
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Phoenix, Arizona, United States, 85016
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Tempe, Arizona, United States, 85281
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California
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Covina, California, United States, 91723
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Encinitas, California, United States, 92024
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Garden Grove, California, United States, 92844
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Loma Linda, California, United States, 92354
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Long Beach, California, United States, 90807
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Pomona, California, United States, 91768
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Sacramento, California, United States, 95821
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Florida
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Crystal River, Florida, United States, 34429
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32209
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Lake City, Florida, United States, 32055
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Leesburg, Florida, United States, 34748
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Orlando, Florida, United States, 32806
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Georgia
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Lilburn, Georgia, United States, 30047
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Idaho
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Idaho Falls, Idaho, United States, 83404
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Illinois
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Melrose Park, Illinois, United States, 60160
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Indiana
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Evansville, Indiana, United States, 47710
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Iowa
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Ames, Iowa, United States, 50010
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Kansas
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Wichita, Kansas, United States, 67226
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Kentucky
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Bowling Green, Kentucky, United States, 42101
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Maryland
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Rockville, Maryland, United States, 20852
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Michigan
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Southfield, Michigan, United States, 48076
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Minnesota
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Minneapolis, Minnesota, United States, 55416
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Missouri
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64114
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Nebraska
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Omaha, Nebraska, United States, 68114
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Nevada
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Henderson, Nevada, United States, 89052
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Las Vegas, Nevada, United States, 89128
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New Mexico
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Albuquerque, New Mexico, United States, 87112
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North Carolina
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Durham, North Carolina, United States, 27701
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Morehead City, North Carolina, United States, 28557
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Raleigh, North Carolina, United States, 27612
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Statesville, North Carolina, United States, 28625
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Wilmington, North Carolina, United States, 28403
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Ohio
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Columbus, Ohio, United States, 43215
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73134
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Pennsylvania
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Feasterville-Trevose, Pennsylvania, United States, 19053
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Philadelphia, Pennsylvania, United States, 19114
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
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North Charleston, South Carolina, United States, 29405
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Tennessee
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Memphis, Tennessee, United States, 38119
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Morristown, Tennessee, United States, 37813
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Texas
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77079
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Houston, Texas, United States, 77004
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Houston, Texas, United States, 77040
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Katy, Texas, United States, 77450
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78231
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Sugar Land, Texas, United States, 77478
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Weslaco, Texas, United States, 78596
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Utah
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Bountiful, Utah, United States, 84010
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Salt Lake City, Utah, United States, 84124
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Virginia
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Leesburg, Virginia, United States, 20176
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Norfolk, Virginia, United States, 23502
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Washington
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Renton, Washington, United States, 98057
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98105
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West Virginia
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Morgantown, West Virginia, United States, 26505
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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(s)
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
- 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 Mellitus (T1DM), 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 Gastrointestinal (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 (NYHA 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Elecoglipron
Participants will receive elecoglipron dose XX mg administered orally once daily.
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Elecoglipron is administered orally once daily.
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Active Comparator: Semaglutide
Participants will receive semaglutide dose XX mg administered orally once daily.
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Semaglutide is administered orally once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline to Week 52
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Baseline to Week 52
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline to Week 52 in body weight
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
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Change from baseline to Week 52 in body weight (kg)
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
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Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
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Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
Time Frame: Week 52
|
Week 52
|
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Achieved HbA1c < 7% (53 mmol/mol) at Week 52
Time Frame: Week 52
|
Week 52
|
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Achieved ≥ 5% weight loss from baseline at Week 52
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
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Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
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)
May 23, 2028
Study Completion (Estimated)
May 23, 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)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 7, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7261C00005
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523933-24-00 (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.