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
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)
2 other identifiers
interventional
1,200
15 countries
201
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jul 2026
Typical duration for phase_3 type-2-diabetes-mellitus
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 23, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2028
July 14, 2026
May 1, 2026
1.9 years
June 18, 2026
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Hemoglobin A1c (HbA1c)
Baseline to Week 52
Secondary Outcomes (7)
Percent change from baseline to Week 52 in body weight
Baseline to Week 52
Change from baseline to Week 52 in body weight (kg)
Baseline to Week 52
Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
Baseline to Week 52
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
Week 52
Achieved HbA1c < 7% (53 mmol/mol) at Week 52
Week 52
- +2 more secondary outcomes
Study Arms (2)
Elecoglipron
EXPERIMENTALParticipants will receive elecoglipron dose XX mg administered orally once daily.
Semaglutide
ACTIVE COMPARATORParticipants will receive semaglutide dose XX mg administered orally once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (201)
Research Site
Birmingham, Alabama, 35205, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85016, United States
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Tempe, Arizona, 85281, United States
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Covina, California, 91723, United States
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Encinitas, California, 92024, United States
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Garden Grove, California, 92844, United States
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Loma Linda, California, 92350, United States
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Long Beach, California, 90807, United States
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Pomona, California, 91768, United States
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Sacramento, California, 95821, United States
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Bridgeport, Connecticut, 06606, United States
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Crystal River, Florida, 34429, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32209, United States
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Leesburg, Florida, 34748, United States
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Orlando, Florida, 32806, United States
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Lilburn, Georgia, 30047, United States
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Idaho Falls, Idaho, 83404, United States
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Melrose Park, Illinois, 60160, United States
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Evansville, Indiana, 47710, United States
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Ames, Iowa, 50010, United States
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Wichita, Kansas, 67226, United States
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Bowling Green, Kentucky, 42101, United States
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Rockville, Maryland, 20852, United States
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Southfield, Michigan, 48076, United States
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Minneapolis, Minnesota, 55416, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64114, United States
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Omaha, Nebraska, 68114, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89128, United States
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Albuquerque, New Mexico, 87112, United States
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Durham, North Carolina, 27701, United States
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Morehead City, North Carolina, 28557, United States
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Raleigh, North Carolina, 27612, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, 28403, United States
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Columbus, Ohio, 43215, United States
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Yukon, Oklahoma, 73099, United States
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Feasterville-Trevose, Pennsylvania, 19053, United States
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Philadelphia, Pennsylvania, 19114, United States
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Myrtle Beach, South Carolina, 29572, United States
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North Charleston, South Carolina, 29405, United States
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Memphis, Tennessee, 38119, United States
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Morristown, Tennessee, 37813, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77040, United States
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Houston, Texas, 77079, United States
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Katy, Texas, 77450, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78231, United States
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Sugar Land, Texas, 77478, United States
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Weslaco, Texas, 78596, United States
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Bountiful, Utah, 84010, United States
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Salt Lake City, Utah, 84124, United States
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Leesburg, Virginia, 20176, United States
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Norfolk, Virginia, 23502, United States
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Renton, Washington, 98057, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98105, United States
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Morgantown, West Virginia, 26505, United States
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Buenos Aires, C1425AGC, Argentina
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CABA, C1120AAC, Argentina
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Caba, C1128AAF, Argentina
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Ciudad de Buenos Aires, C1094AAD, Argentina
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Rosario, S2000CVD, Argentina
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San Nicolás, B2900DMH, Argentina
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San Vicente, 5006, Argentina
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Botany, 2019, Australia
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East Toowoomba, 4350, Australia
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Fitzroy, 3065, Australia
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Heidelberg Heights, 3081, Australia
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Kingswood, 2747, Australia
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Melbourne, 3004, Australia
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Parkville, 3050, Australia
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St Leonards, 2065, Australia
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Brasília, 71625-009, Brazil
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Campinas, 13060-904, Brazil
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Curitiba, 80030-480, Brazil
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Natal, 59020-035, Brazil
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Porto Alegre, 90630-165, Brazil
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São José dos Campos, 12243-280, Brazil
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São Paulo, 04012-180, Brazil
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Plovdiv, 4001, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1700, Bulgaria
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Yambol, 8600, Bulgaria
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Vancouver, British Columbia, V5Y 3W2, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Scarborough Village, Ontario, M1R 0B1, Canada
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Stouffville, Ontario, L4A1H2, Canada
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Toronto, Ontario, M4G3E8, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Changsha, 410013, China
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Changsha, 410015, China
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Hefei, 230000, China
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Hefei, 230601, China
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Huai'an, 223005, China
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Langfang, 065000, China
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Liangyugang, 222002, China
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Luoyang, 471009, China
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Nanjing, 2100008, China
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Nanyang, 473009, China
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Pinggu, 101200, China
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Pingxiang, 337055, China
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Shijiazhuang, 050000, China
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Tianjin, 300134, China
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Yueyang, 414000, China
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Bad Oeynhausen, 32545, Germany
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Berlin, 13597, Germany
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Chemnitz, 09116, Germany
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Damme, 49401, Germany
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Duisburg, 47051, Germany
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Elsterwerda, 04910, Germany
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Erlangen, 91054, Germany
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Essen, 45359, Germany
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Falkensee, 14612, Germany
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Gladbeck, 45968, Germany
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Hamburg, 21109, Germany
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Hamburg, 22607, Germany
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Leipzig, 04249, Germany
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Mannheim, 68167, Germany
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Münster, 48145, Germany
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Oldenburg, 23758, Germany
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Pirna, 01796, Germany
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Sankt Ingbert, 66386, Germany
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Wangen, 88239, Germany
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Budapest, 1036, Hungary
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Budapest, 1089, Hungary
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Budapest, 1132, Hungary
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Debrecen, 4032, Hungary
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Salgótarján, 3100, Hungary
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Szeged, 6725, Hungary
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Szolnok, 5000, Hungary
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Zalaegerszeg, 8900, Hungary
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Chieti, 66100, Italy
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Milan, 20132, Italy
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Milan, 20138, Italy
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Modena, 41100, Italy
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Naples, 80138, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Asahikawa-shi, 070-8530, Japan
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Chūōku, 103-0002, Japan
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Kamakura-shi, 247-0056, Japan
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Koga-shi, 306-0232, Japan
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Mitaka-shi, 181-0013, Japan
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Mito, 310-0826, Japan
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Miyazaki, 880-0034, Japan
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Nagoya, 467-8602, Japan
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Nagoya, 468-0009, Japan
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Naka, 311-0113, Japan
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Naka, 311-0133, Japan
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Nishinomiya-shi, 663-8113, Japan
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Sapporo, 062-0007, Japan
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Takamatsu, 760-0018, Japan
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Bialystok, 15-897, Poland
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Krakow, 31-261, Poland
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Lodz, 90-338, Poland
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Lublin, 20-718, Poland
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Poznan, 60-354, Poland
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Radom, 26-600, Poland
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Warsaw, 00-124, Poland
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Warsaw, 02-507, Poland
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Daegu, 41404, South Korea
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Daejeon, 35015, South Korea
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Guri-si, 11923, South Korea
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Incheon, 21565, South Korea
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Seoul, 05278, South Korea
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Seoul, 06351, South Korea
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Changhua, 50006, Taiwan
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Kaohsiung City, 81362, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 333, Taiwan
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Yung Kang City, 71044, Taiwan
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Aberdeen, AB25 2ZN, United Kingdom
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Addlestone, KT15 2BH, United Kingdom
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Banbury, OX16 9AD, United Kingdom
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Bristol, BS34 5TF, United Kingdom
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Bristol, BS34 6BQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Hounslow, TW3 3LN, United Kingdom
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Penzance, TR18 3DX, United Kingdom
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Poole, BH16 5PW, United Kingdom
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Soham, CB7 5JD, United Kingdom
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Wansford, PE8 6PL, United Kingdom
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Yate, BS37 4AX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 23, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
May 23, 2028
Study Completion (Estimated)
May 23, 2028
Last Updated
July 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.