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)

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: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Elecoglipron; Drug: Dapagliflozin; Drug: Dapagliflozin-matched placebo; Drug: Elecoglipron-matched placebo

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 3

Contacts and Locations

• 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
    • Research Site
  • Buenos Aires, Argentina, C1012AAR
    • Research Site
  • CABA, Argentina, C1120AAC
    • Research Site
  • Caba, Argentina, C1128AAF
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1094AAD
    • Research Site
  • Mar del Plata, Argentina, B7600GNY
    • Research Site
  • Rosario, Argentina, S2000CVD
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
  • San Vicente, Argentina, 5006
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Brasília, Brazil, 71625-009
    • Research Site
  • Campinas, Brazil, 13060-904
    • Research Site
  • Curitiba, Brazil, 80030-480
    • Research Site
  • Fortaleza, Brazil, 60430-350
    • Research Site
  • Natal, Brazil, 59020-035
    • Research Site
  • Porto Alegre, Brazil, 90630-165
    • Research Site
  • Rio de Janeiro, Brazil, 22270-060
    • Research Site
  • São José dos Campos, Brazil, 12243-280
    • Research Site
  • São Paulo, Brazil, 01228-200
    • Research Site
  • São Paulo, Brazil, 04012-180
    • Research Site
• China
  • Baotou, China
    • Research Site
  • Beijing, China, 100050
    • Research Site
  • Changde, China, 415000
    • Research Site
  • Changsha, China, 410015
    • Research Site
  • Changzhou, China, 272100
    • Research Site
  • Chengdu, China, 611130
    • Research Site
  • Chenzhou, China, 423000
    • Research Site
  • Chifeng, China, 024000
    • Research Site
  • Hangzhou, China, 310014
    • Research Site
  • Hefei, China, 230601
    • Research Site
  • Huai'an, China, 223005
    • Research Site
  • Kaifeng, China, 475000
    • Research Site
  • Liangyugang, China, 222002
    • Research Site
  • Luoyang, China, 471009
    • Research Site
  • Nanjing, China, 210011
    • Research Site
  • Nanyang, China, 473009
    • Research Site
  • Sanya, China, 572000
    • Research Site
  • Shanghai, China, 201199
    • Research Site
  • Shantou, China, 515065
    • Research Site
  • Shenyang, China, 110023
    • Research Site
  • Shijiazhuang, China, 050001
    • Research Site
  • Shijiazhuang, China, 050000
    • Research Site
  • Wuhan, China, 430010
    • Research Site
  • Wuhu, China, 241004
    • Research Site
  • Xi'an, China, 710077
    • Research Site
  • Xiangyang, China, 441000
    • Research Site
  • Xianyang, China, 712000
    • Research Site
  • Xuzhou, China, 221009
    • Research Site
  • Yan’an, China, 716000
    • Research Site
  • Zhumadian, China, 463000
    • Research Site
• Czechia
  • Hradec Králové, Czechia, 500 02
    • Research Site
  • Humpolec, Czechia, 396 01
    • Research Site
  • Jílové u Prahy, Czechia, 254 01
    • Research Site
  • Ostrava, Czechia, 702 00
    • Research Site
  • Prague, Czechia, 160 00
    • Research Site
  • Prague, Czechia, 149 00
    • Research Site
  • Prague, Czechia, 147 00
    • Research Site
  • Příbram, Czechia, 261 01
    • Research Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Research Site
  • Esbjerg, Denmark, 6700
    • Research Site
  • Gandrup, Denmark, 9362
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Hillerød, Denmark, 3400
    • Research Site
  • Hvidovre, Denmark, 2650
    • Research Site
  • Odense, Denmark, 5000
    • Research Site
• Germany
  • Berlin, Germany, 13597
    • Research Site
  • Cologne, Germany, 51069
    • Research Site
  • Damme, Germany, 49401
    • Research Site
  • Deggingen, Germany, 73326
    • Research Site
  • Duisburg, Germany, 47269
    • Research Site
  • Essen, Germany, 45355
    • Research Site
  • Falkensee, Germany, 14612
    • Research Site
  • Frankfurt, Germany, 60596
    • Research Site
  • Hamburg, Germany, 22607
    • Research Site
  • Leipzig, Germany, 04249
    • Research Site
  • Münster, Germany, 48145
    • Research Site
  • Nittendorf, Germany, 93152
    • Research Site
  • Pohlheim, Germany, 35415
    • Research Site
  • Villingen-Schwenningen, Germany, 78048
    • Research Site
  • Wallerfing, Germany, 94574
    • Research Site
  • Weinheim, Germany, 69469
    • Research Site
• Greece
  • Alexandroupoli, Greece, 68100
    • Research Site
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 17562
    • Research Site
  • Athens, Greece, 115 25
    • Research Site
  • Ioannina, Greece, 45500
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
  • Thessaloniki, Greece, 54642
    • Research Site
  • Thessaloniki, Greece, 54635
    • Research Site
• Hungary
  • Budapest, Hungary, 1036
    • Research Site
  • Budapest, Hungary, 1089
    • Research Site
  • Budapest, Hungary, 1132
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Salgótarján, Hungary, 3100
    • Research Site
  • Szeged, Hungary, 6725
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• Japan
  • Hachioji-shi, Japan, 192-0083
    • Research Site
  • Ichikawa-shi, Japan, 272-8516
    • Research Site
• Malaysia
  • Alor Star, Malaysia, 05400
    • Research Site
  • Ipoh, Malaysia, 30450
    • Research Site
  • Kangar, Malaysia, 01000
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Sarawak Miri, Malaysia, 98000
    • Research Site
  • Seremban, Malaysia, 70300
    • Research Site
  • Seri Manjung, Malaysia, 32040
    • Research Site
• Poland
  • Bialystok, Poland, 15-897
    • Research Site
  • Częstochowa, Poland, 42-217
    • Research Site
  • Kielce, Poland, 25-355
    • Research Site
  • Lodz, Poland, 90-338
    • Research Site
  • Lublin, Poland, 20-718
    • Research Site
  • Poznan, Poland, 60-354
    • Research Site
  • Radom, Poland, 26-600
    • Research Site
  • Warsaw, Poland, 02-507
    • Research Site
  • Warsaw, Poland, 00-124
    • Research Site
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Research Site
• South Korea
  • Goyang-si, South Korea, 411-706
    • Research Site
  • Guri-si, South Korea, 11923
    • Research Site
  • Gwangju, South Korea, 61453
    • Research Site
  • Gyeonggi-do, South Korea, 13620
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 06273
    • Research Site
  • Seoul, South Korea, 136-705
    • Research Site
  • Yangsan, South Korea, 50612
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Kaohsiung City, Taiwan, 80756
    • Research Site
  • Kaohsiung City, Taiwan, 813
    • Research Site
  • New Taipei City, Taiwan, 220
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Taichung, Taiwan, 433004
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Tainan County, Taiwan, 71044
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
• Ukraine
  • Kyiv, Ukraine, 04114
    • Research Site
  • Kyiv, Ukraine, 02002
    • Research Site
  • Kyiv, Ukraine, 03037
    • Research Site
  • Kyiv, Ukraine, 03049
    • Research Site
  • Kyiv, Ukraine, 03057
    • Research Site
  • Kyiv, Ukraine, 04210
    • Research Site
  • Lviv, Ukraine, 79010
    • Research Site
  • Lviv, Ukraine, 79016
    • Research Site
  • Uzhhorod, Ukraine, 88014
    • Research Site
  • Uzhhorod, Ukraine, 88002
    • Research Site
  • Vinnytsia, Ukraine, 21001
    • Research Site
• United Kingdom
  • Blackburn, United Kingdom, BB2 1AX
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Research Site
  • Guisborough, United Kingdom, TS14 7DJ
    • Research Site
  • Nantwich, United Kingdom, CW5 5NX
    • Research Site
  • Rotherham, United Kingdom, S65 1DA
    • Research Site
  • Stowmarket, United Kingdom, IP142SY
    • Research Site
  • Thetford, United Kingdom, IP24 1JD
    • Research Site
  • Weston-super-Mare, United Kingdom, BS24 7PR
    • Research Site
  • Witney, United Kingdom, OX28 6JS
    • Research Site
  • Yate, United Kingdom, BS37 4AX
    • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Research Site
  • California
    • Los Angeles, California, United States, 90017
      • Research Site
    • Ontario, California, United States, 91762
      • Research Site
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Research Site
  • Louisiana
    • Zachary, Louisiana, United States, 70791
      • Research Site
  • Maryland
    • Lutherville-Timonium, Maryland, United States, 21093
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Research Site
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Research Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Research Site
  • Texas
    • McKinney, Texas, United States, 75069
      • Research Site
  • Utah
    • South Jordan, Utah, United States, 84095
      • Research Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Research Site
  • Washington
    • Redmond, Washington, United States, 98052
      • Research Site
  • West Virginia
    • Kingwood, West Virginia, United States, 26537
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Hochiminh, Vietnam, 700000
    • Research Site
  • Hochiminh City, Vietnam, 700000
    • Research Site
  • Huế, Vietnam, 530000
    • Research Site
  • Hồ Chí Minh, Vietnam, 700000
    • Research Site
  • Rach Gia, Vietnam, 920000
    • Research Site

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

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)	Baseline to Week 40

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): 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): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; dapagliflozin
• 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: No