A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus (Eluminate-5)

July 14, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Recruiting

Conditions

Type 2 Diabetes Mellitus

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

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

Argentina
- - Buenos Aires, Argentina, C1425AGC
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1012AAR
    - Not yet recruiting
    - Research Site
  - CABA, Argentina, C1120AAC
    - Not yet recruiting
    - Research Site
  - Caba, Argentina, C1128AAF
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1094AAD
    - Not yet recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GNY
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, S2000CVD
    - Not yet recruiting
    - Research Site
  - San Nicolás, Argentina, B2900DMH
    - Not yet recruiting
    - Research Site
  - San Vicente, Argentina, 5006
    - Not yet recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Not yet recruiting
    - Research Site
  - Brasília, Brazil, 71625-009
    - Not yet recruiting
    - Research Site
  - Campinas, Brazil, 13060-904
    - Not yet recruiting
    - Research Site
  - Curitiba, Brazil, 80030-480
    - Not yet recruiting
    - Research Site
  - Fortaleza, Brazil, 60430-350
    - Not yet recruiting
    - Research Site
  - Natal, Brazil, 59020-035
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90630-165
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22270-060
    - Not yet recruiting
    - Research Site
  - São José dos Campos, Brazil, 12243-280
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 01228-200
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Not yet recruiting
    - Research Site
China
- - Baotou, China
    - Not yet recruiting
    - Research Site
  - Beijing, China, 102218
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100050
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100044
    - Not yet recruiting
    - Research Site
  - Changde, China, 415000
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410015
    - Not yet recruiting
    - Research Site
  - Changzhou, China, 272100
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 611130
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610078
    - Not yet recruiting
    - Research Site
  - Chenzhou, China, 423000
    - Not yet recruiting
    - Research Site
  - Chifeng, China, 024000
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Not yet recruiting
    - Research Site
  - Hefei, China, 230601
    - Not yet recruiting
    - Research Site
  - Huai'an, China, 223005
    - Not yet recruiting
    - Research Site
  - Jinan, China, 250031
    - Not yet recruiting
    - Research Site
  - Jincheng, China, 048000
    - Not yet recruiting
    - Research Site
  - Jining, China, 272006
    - Not yet recruiting
    - Research Site
  - Jinzhou Shi, China, 121001
    - Not yet recruiting
    - Research Site
  - Kaifeng, China, 475000
    - Not yet recruiting
    - Research Site
  - Langfang, China, 065000
    - Not yet recruiting
    - Research Site
  - Liangyugang, China, 222002
    - Not yet recruiting
    - Research Site
  - Luoyang, China, 471009
    - Not yet recruiting
    - Research Site
  - Meihekou, China, 135022
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210011
    - Not yet recruiting
    - Research Site
  - Nantong, China, 226001
    - Not yet recruiting
    - Research Site
  - Nanyang, China, 473009
    - Not yet recruiting
    - Research Site
  - Pinggu, China, 101200
    - Not yet recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Not yet recruiting
    - Research Site
  - Sanya, China, 572000
    - Withdrawn
    - Research Site
  - Shanghai, China, 200062
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 201199
    - Not yet recruiting
    - Research Site
  - Shantou, China, 515065
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110004
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110023
    - Not yet recruiting
    - Research Site
  - Shijiazhuang, China, 050000
    - Not yet recruiting
    - Research Site
  - Shijiazhuang, China, 050001
    - Not yet recruiting
    - Research Site
  - Tianjin, China, 300000
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430010
    - Not yet recruiting
    - Research Site
  - Wuhu, China, 241004
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710077
    - Not yet recruiting
    - Research Site
  - Xiangyang, China, 441000
    - Not yet recruiting
    - Research Site
  - Xianyang, China, 712000
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Not yet recruiting
    - Research Site
  - Yan’an, China, 716000
    - Not yet recruiting
    - Research Site
  - Yueyang, China, 414000
    - Not yet recruiting
    - Research Site
  - Zhumadian, China, 463000
    - Not yet recruiting
    - Research Site
  - Zibo, China, 255499
    - Not yet recruiting
    - Research Site
Czechia
- - Hradec Králové, Czechia, 500 02
    - Not yet recruiting
    - Research Site
  - Humpolec, Czechia, 396 01
    - Not yet recruiting
    - Research Site
  - Jílové u Prahy, Czechia, 254 01
    - Not yet recruiting
    - Research Site
  - Ostrava, Czechia, 702 00
    - Not yet recruiting
    - Research Site
  - Prague, Czechia, 149 00
    - Not yet recruiting
    - Research Site
  - Prague, Czechia, 147 00
    - Not yet recruiting
    - Research Site
  - Prague, Czechia, 160 00
    - Not yet recruiting
    - Research Site
  - Příbram, Czechia, 261 01
    - Not yet recruiting
    - Research Site
Denmark
- - Aarhus N, Denmark, 8200
    - Not yet recruiting
    - Research Site
  - Esbjerg, Denmark, 6700
    - Not yet recruiting
    - Research Site
  - Gandrup, Denmark, 9362
    - Not yet recruiting
    - Research Site
  - Herlev, Denmark, 2730
    - Not yet recruiting
    - Research Site
  - Hillerød, Denmark, 3400
    - Not yet recruiting
    - Research Site
  - Hvidovre, Denmark, 2650
    - Not yet recruiting
    - Research Site
  - Odense, Denmark, 5000
    - Not yet recruiting
    - Research Site
Germany
- - Berlin, Germany, 13597
    - Not yet recruiting
    - Research Site
  - Cologne, Germany, 51069
    - Not yet recruiting
    - Research Site
  - Damme, Germany, 49401
    - Not yet recruiting
    - Research Site
  - Deggingen, Germany, 73326
    - Not yet recruiting
    - Research Site
  - Duisburg, Germany, 47269
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45355
    - Not yet recruiting
    - Research Site
  - Falkensee, Germany, 14612
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60596
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 22607
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04249
    - Not yet recruiting
    - Research Site
  - Münster, Germany, 48145
    - Not yet recruiting
    - Research Site
  - Nittendorf, Germany, 93152
    - Not yet recruiting
    - Research Site
  - Pohlheim, Germany, 35415
    - Not yet recruiting
    - Research Site
  - Villingen-Schwenningen, Germany, 78048
    - Withdrawn
    - Research Site
  - Wallerfing, Germany, 94574
    - Not yet recruiting
    - Research Site
  - Weinheim, Germany, 69469
    - Not yet recruiting
    - Research Site
Greece
- - Alexandroupoli, Greece, 68100
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 11527
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 17562
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 115 25
    - Not yet recruiting
    - Research Site
  - Ioannina, Greece, 45500
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 54645
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 54642
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 54635
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1036
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1089
    - Suspended
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Salgótarján, Hungary, 3100
    - Not yet recruiting
    - Research Site
  - Szeged, Hungary, 6725
    - Not yet recruiting
    - Research Site
  - Szolnok, Hungary, 5000
    - Not yet recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Not yet recruiting
    - Research Site
India
- - Bangalore, India, 560 092
    - Not yet recruiting
    - Research Site
  - Belagavi, India, 590010
    - Not yet recruiting
    - Research Site
  - Belagavi, India, 590006
    - Not yet recruiting
    - Research Site
  - Calicut, India, 673008
    - Not yet recruiting
    - Research Site
  - Chennai, India, 600086
    - Not yet recruiting
    - Research Site
  - Coimbatore, India, 641018
    - Not yet recruiting
    - Research Site
  - Guwahati, India, 781032
    - Not yet recruiting
    - Research Site
  - Indore, India, 452008
    - Not yet recruiting
    - Research Site
  - Jaipur, India, 302017
    - Not yet recruiting
    - Research Site
  - Kochi, India, 682040
    - Not yet recruiting
    - Research Site
  - Kochi, India, 682041
    - Not yet recruiting
    - Research Site
  - Lucknow, India, 226030
    - Not yet recruiting
    - Research Site
  - Madurai, India, 625020
    - Not yet recruiting
    - Research Site
  - Mumbai, India, 400012
    - Not yet recruiting
    - Research Site
  - Nagpur, India, 440010
    - Not yet recruiting
    - Research Site
  - New Delhi, India, 11029
    - Not yet recruiting
    - Research Site
  - Thiruvananthapuram, India, 695031
    - Not yet recruiting
    - Research Site
Japan
- - Chūōku, Japan, 103-0027
    - Not yet recruiting
    - Research Site
  - Hachioji-shi, Japan, 192-0083
    - Not yet recruiting
    - Research Site
  - Ichikawa-shi, Japan, 272-8516
    - Not yet recruiting
    - Research Site
  - Kishiwada-shi, Japan, 596-8501
    - Not yet recruiting
    - Research Site
  - Meguro-ku, Japan, 153-0053
    - Not yet recruiting
    - Research Site
  - Mito, Japan, 310-0826
    - Not yet recruiting
    - Research Site
  - Sapporo, Japan, 060-0061
    - Not yet recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-0008
    - Not yet recruiting
    - Research Site
  - Yamato-shi, Japan, 242-0004
    - Not yet recruiting
    - Research Site
Malaysia
- - Alor Star, Malaysia, 05400
    - Not yet recruiting
    - Research Site
  - Ipoh, Malaysia, 30450
    - Not yet recruiting
    - Research Site
  - Kangar, Malaysia, 01000
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Not yet recruiting
    - Research Site
  - Sarawak Miri, Malaysia, 98000
    - Not yet recruiting
    - Research Site
  - Seremban, Malaysia, 70300
    - Not yet recruiting
    - Research Site
  - Seri Manjung, Malaysia, 32040
    - Not yet recruiting
    - Research Site
Mexico
- - Cuernavaca, Mexico, 62448
    - Not yet recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-897
    - Not yet recruiting
    - Research Site
  - Częstochowa, Poland, 42-217
    - Not yet recruiting
    - Research Site
  - Kielce, Poland, 25-355
    - Not yet recruiting
    - Research Site
  - Lodz, Poland, 90-338
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-718
    - Not yet recruiting
    - Research Site
  - Poznan, Poland, 60-354
    - Not yet recruiting
    - Research Site
  - Radom, Poland, 26-600
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 00-124
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 02-507
    - Not yet recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00918
    - Not yet recruiting
    - Research Site
South Africa
- - Brackenfell, South Africa, 7560
    - Not yet recruiting
    - Research Site
  - Cape Town, South Africa, 7570
    - Not yet recruiting
    - Research Site
  - Cape Town, South Africa, 7500
    - Not yet recruiting
    - Research Site
  - Claremont, South Africa, 7708
    - Not yet recruiting
    - Research Site
  - Durban, South Africa, 4093
    - Not yet recruiting
    - Research Site
  - Durban, South Africa, 4091
    - Not yet recruiting
    - Research Site
  - Johannesburg, South Africa, 1827
    - Not yet recruiting
    - Research Site
  - KwaDukuza, South Africa, 4449
    - Not yet recruiting
    - Research Site
  - Paarl, South Africa, 7646
    - Not yet recruiting
    - Research Site
  - Pretoria, South Africa
    - Not yet recruiting
    - Research Site
  - eMkhomazi, South Africa, 4170
    - Not yet recruiting
    - Research Site
South Korea
- - Goyang-si, South Korea, 411-706
    - Not yet recruiting
    - Research Site
  - Guri-si, South Korea, 11923
    - Not yet recruiting
    - Research Site
  - Gwangju, South Korea, 61453
    - Not yet recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 06273
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 136-705
    - Not yet recruiting
    - Research Site
  - Yangsan, South Korea, 50612
    - Not yet recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 500
    - Not yet recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 813
    - Not yet recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Not yet recruiting
    - Research Site
  - New Taipei City, Taiwan, 24352
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40201
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 433004
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 70403
    - Not yet recruiting
    - Research Site
  - Tainan County, Taiwan, 71044
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Not yet recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Not yet recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Not yet recruiting
    - Research Site
  - Banphaeo, Thailand, 74120
    - Not yet recruiting
    - Research Site
  - Changwat Sara Buri, Thailand, 18000
    - Not yet recruiting
    - Research Site
  - Khlong Luang, Thailand, 12120
    - Not yet recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 70000
    - Not yet recruiting
    - Research Site
  - Mueang, Thailand, 20000
    - Not yet recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Not yet recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 6200
    - Not yet recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06540
    - Not yet recruiting
    - Research Site
  - Gaziantep, Turkey (Türkiye), 27470
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34010
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34384
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34265
    - Not yet recruiting
    - Research Site
  - Konya, Turkey (Türkiye), 42130
    - Not yet recruiting
    - Research Site
Ukraine
- - Kyiv, Ukraine, 02002
    - Not yet recruiting
    - Research Site
  - Kyiv, Ukraine, 03037
    - Not yet recruiting
    - Research Site
  - Kyiv, Ukraine, 04210
    - Not yet recruiting
    - Research Site
  - Kyiv, Ukraine, 03057
    - Not yet recruiting
    - Research Site
  - Kyiv, Ukraine, 03049
    - Not yet recruiting
    - Research Site
  - Kyiv, Ukraine, 04114
    - Not yet recruiting
    - Research Site
  - Lviv, Ukraine, 79010
    - Not yet recruiting
    - Research Site
  - Lviv, Ukraine, 79016
    - Not yet recruiting
    - Research Site
  - Uzhhorod, Ukraine, 88014
    - Not yet recruiting
    - Research Site
  - Uzhhorod, Ukraine, 88002
    - Not yet recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Not yet recruiting
    - Research Site
United Kingdom
- - Blackburn, United Kingdom, BB2 1AX
    - Not yet recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Not yet recruiting
    - Research Site
  - Guisborough, United Kingdom, TS14 7DJ
    - Not yet recruiting
    - Research Site
  - Nantwich, United Kingdom, CW5 5NX
    - Not yet recruiting
    - Research Site
  - Rotherham, United Kingdom, S65 1DA
    - Not yet recruiting
    - Research Site
  - Thetford, United Kingdom, IP24 1JD
    - Not yet recruiting
    - Research Site
  - Weston-super-Mare, United Kingdom, BS24 7PR
    - Recruiting
    - Research Site
  - Witney, United Kingdom, OX28 6JS
    - Recruiting
    - Research Site
  - Woodbridge, United Kingdom, IP136TH
    - Not yet recruiting
    - Research Site
  - Yate, United Kingdom, BS37 4AX
    - Not yet recruiting
    - Research Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35801
    - Not yet recruiting
    - Research Site
  - Mobile, Alabama, United States, 36608
    - Not yet recruiting
    - Research Site
  - Sheffield, Alabama, United States, 35660
    - Not yet recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Not yet recruiting
    - Research Site
- California
  - Bakersfield, California, United States, 93309
    - Not yet recruiting
    - Research Site
  - Los Angeles, California, United States, 90017
    - Not yet recruiting
    - Research Site
  - Ontario, California, United States, 91762
    - Not yet recruiting
    - Research Site
- Florida
  - Lake City, Florida, United States, 32055
    - Not yet recruiting
    - Research Site
  - Lakeland, Florida, United States, 33813
    - Not yet recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30315
    - Not yet recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60640
    - Not yet recruiting
    - Research Site
  - Skokie, Illinois, United States, 60077
    - Not yet recruiting
    - Research Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - Not yet recruiting
    - Research Site
- Iowa
  - Sioux City, Iowa, United States, 51106
    - Not yet recruiting
    - Research Site
- Louisiana
  - Zachary, Louisiana, United States, 70791
    - Not yet recruiting
    - Research Site
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Not yet recruiting
    - Research Site
  - Lutherville-Timonium, Maryland, United States, 21093
    - Not yet recruiting
    - Research Site
  - Oxon Hill, Maryland, United States, 20745
    - Not yet recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Research Site
  - Boston, Massachusetts, United States, 02115
    - Not yet recruiting
    - Research Site
- Michigan
  - Troy, Michigan, United States, 48098
    - Not yet recruiting
    - Research Site
- Mississippi
  - Ridgeland, Mississippi, United States, 39157
    - Not yet recruiting
    - Research Site
- Nebraska
  - Elkhorn, Nebraska, United States, 68022
    - Not yet recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87112
    - Not yet recruiting
    - Research Site
- New York
  - Brooklyn, New York, United States, 11201
    - Not yet recruiting
    - Research Site
- North Carolina
  - Raleigh, North Carolina, United States, 27607
    - Not yet recruiting
    - Research Site
- Ohio
  - Beachwood, Ohio, United States, 44122
    - Not yet recruiting
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Not yet recruiting
    - Research Site
- Oklahoma
  - Norman, Oklahoma, United States, 73069
    - Not yet recruiting
    - Research Site
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Not yet recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Research Site
- Texas
  - Dallas, Texas, United States, 75230
    - Not yet recruiting
    - Research Site
  - McKinney, Texas, United States, 75069
    - Not yet recruiting
    - Research Site
  - Paris, Texas, United States, 75462
    - Not yet recruiting
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Not yet recruiting
    - Research Site
- Utah
  - South Jordan, Utah, United States, 84095
    - Withdrawn
    - Research Site
- Virginia
  - Arlington, Virginia, United States, 22205
    - Not yet recruiting
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Not yet recruiting
    - Research Site
- Washington
  - Redmond, Washington, United States, 98052
    - Not yet recruiting
    - Research Site
- West Virginia
  - Kingwood, West Virginia, United States, 26537
    - Not yet recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 10000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Hochiminh, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Hochiminh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Huế, Vietnam, 530000
    - Not yet recruiting
    - Research Site
  - Hồ Chí Minh, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Rach Gia, Vietnam, 920000
    - Not yet recruiting
    - Research Site

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elecoglipron dose level 1 + dapagliflozin Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.	Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin Dapagliflozin administered orally once daily.
Experimental: Elecoglipron dose level 2 + dapagliflozin Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.	Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin Dapagliflozin administered orally once daily.
Experimental: Elecoglipron dose level 1 + dapagliflozin-matched placebo Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.	Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin-matched placebo A placebo matching dapagliflozin administered orally once daily.
Experimental: Elecoglipron dose level 2 + dapagliflozin-matched placebo Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.	Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin-matched placebo A placebo matching dapagliflozin administered orally once daily.
Active Comparator: Elecoglipron-matched placebo + dapagliflozin Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.	Drug: Dapagliflozin Dapagliflozin administered orally once daily. Drug: Elecoglipron-matched placebo A placebo matching elecoglipron administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Hemoglobin A1c (HbA1c) Time Frame: Baseline to Week 40	Baseline to Week 40

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Hemoglobin A1c (HbA1c) Time Frame: Baseline to Week 40	Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol) Time Frame: Week 40	Week 40
Percent change in body weight Time Frame: Baseline to Week 40	Baseline to Week 40
Change from baseline in body weight Time Frame: Baseline to Week 40	Baseline to Week 40
Change from baseline in Systolic Blood Pressure (SBP) Time Frame: Baseline to Week 40	Baseline to Week 40
Change from baseline in Fasting Plasma Glucose (FPG) Time Frame: Baseline to Week 40	Baseline to Week 40
Time to initiation of rescue medication over 40 weeks Time Frame: Baseline to Week 40	Baseline to Week 40
Change from baseline in Diastolic Blood Pressure (DBP) Time Frame: Baseline to Week 40	Baseline to Week 40
Change from baseline in daily mean 7-point Self-Monitored Blood Glucose (SMBG) Time Frame: Baseline to Week 40	Baseline to Week 40
Achievement of ≥ 5% weight loss from baseline Time Frame: Baseline to Week 40	Baseline to Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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 5, 2028

Study Completion (Estimated)

July 5, 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)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D7261C00003
2025-523941-81-00 (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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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