A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)

June 18, 2026 updated by: AstraZeneca

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • 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
      • San Nicolás, Argentina, B2900DMH
        • Research Site
      • San Vicente, Argentina, 5006
        • Research Site
      • Santa Fe, Argentina, S3000FWO
        • Research Site
  • China
      • Baotou, China, 014030
        • Research Site
      • Binzhou, China, 256606
        • Research Site
      • Cangzhou, China, 061002
        • Research Site
      • Changsha, China, 430033
        • Research Site
      • Chengdu, China, 610081
        • Research Site
      • Ganzhou, China, 341099
        • Research Site
      • Haikou, China, 570208
        • Research Site
      • Hangzhou, China, 310006
        • Research Site
      • Huangshi, China, 435000
        • Research Site
      • Huzhou, China, 313003
        • Research Site
      • Jinan, China, 250013
        • Research Site
      • Jinzhou, China, 121002
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Lianyungang, China, 222023
        • Research Site
      • Liaocheng, China, 252000
        • Research Site
      • Liuzhou, China, 545006
        • Research Site
      • Loudi, China, 417099
        • Research Site
      • Luoyang, China, 471003
        • Research Site
      • Luoyang, China, 471001
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 211100
        • Research Site
      • Nanjing, China, 2100008
        • Research Site
      • Nanyang, China, 473000
        • Research Site
      • Ningbo, China, 315010
        • Research Site
      • Panjin, China, 124000
        • Research Site
      • Qingdao, China, 266035
        • Research Site
      • Sanmenxia, China, 472000
        • Research Site
      • Shanghai, China, 200040
        • Research Site
      • Suining Shi, China, 629000
        • Research Site
      • Tonghua, China, 134000
        • Research Site
      • Xi'an, China, 710077
        • Research Site
      • Xiangtan, China, 411100
        • Research Site
      • Xuancheng, China, 242000
        • Research Site
      • Yibin, China, 610500
        • Research Site
      • Yichang, China, 443003
        • Research Site
      • Yuncheng, China, 044099
        • Research Site
      • Zhengzhou, China, 450012
        • Research Site
      • Zhengzhou, China, 450002
        • Research Site
      • Zhenjiang, China, 212002
        • Research Site
  • Denmark
      • Gandrup, Denmark, 9362
        • Research Site
      • Herlev, Denmark, 2730
        • Research Site
      • Hillerød, Denmark, 3400
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
  • Greece
      • Athens, Greece, 10676
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Athens, Greece, 15125
        • Research Site
      • Athens, Greece, 12131
        • Research Site
      • Heraklion, Greece, 71500
        • Research Site
      • Piraeus, Greece, 18454
        • Research Site
      • Thessaloniki, Greece, 57010
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
      • Thessaloniki, Greece, 57001
        • Research Site
  • Hungary
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1027
        • Research Site
      • Budapest, Hungary, 1138
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Dunaújváros, Hungary, 2400
        • Research Site
      • Szeged, Hungary, 6725
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
  • Japan
      • Amagasaki-shi, Japan, 660-8550
        • Research Site
      • Chiba, Japan, 261-0004
        • Research Site
      • Chūōku, Japan, 1040031
        • Research Site
      • Minatoku, Japan, 105-0004
        • Research Site
      • Okayama, Japan, 701-1192
        • Research Site
      • Shinjuku-ku, Japan, 169-0072
        • Research Site
      • Zentsuji-shi, Japan, 765-0071
        • Research Site
  • South Africa
      • Brackenfell, South Africa, 7560
        • Research Site
      • Cape Town, South Africa, 7570
        • Research Site
      • Cape Town, South Africa, 7500
        • Research Site
      • Claremont, South Africa, 7708
        • Research Site
      • Durban, South Africa, 4093
        • Research Site
      • Johannesburg, South Africa, 1827
        • Research Site
      • KwaDukuza, South Africa, 4449
        • Research Site
      • Paarl, South Africa, 7646
        • Research Site
      • Pretoria, South Africa, 2
        • Research Site
      • eMkhomazi, South Africa, 4170
        • Research Site
  • South Korea
      • Jongno-gu, South Korea, 110-746
        • Research Site
      • Seongnam-si, South Korea, 463-712
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 5505
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08016
        • Research Site
      • Barcelona, Spain, 08020
        • Research Site
      • Barcelona, Spain, 08930
        • Research Site
      • Figueres, Spain, 17600
        • Research Site
      • Seville, Spain, 41003
        • Research Site
      • Seville, Spain, 41950
        • 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
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Research Site
      • Ankara, Turkey (Türkiye), 06530
        • Research Site
      • Ankara, Turkey (Türkiye), 06560
        • Research Site
      • Bursa, Turkey (Türkiye), 16310
        • Research Site
      • Izmir, Turkey (Türkiye), 35340
        • Research Site
      • Kayseri, Turkey (Türkiye), 38039
        • Research Site
      • Samsun, Turkey (Türkiye), 55139
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
      • Daphne, Alabama, United States, 36526
        • Research Site
    • California
      • Lomita, California, United States, 90717
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Research Site
      • San Diego, California, United States, 92111
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Research Site
      • Decatur, Georgia, United States, 30030
        • Research Site
      • Hinesville, Georgia, United States, 31313
        • Research Site
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Research Site
      • Newton, Kansas, United States, 67114
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Research Site
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Research Site
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • St Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Research Site
    • Texas
      • Irving, Texas, United States, 75061
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • 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

No

Description

Inclusion Criteria:

  • Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
  • T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
  • HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
  • Body mass index (BMI) of ≥ 23 kg/m2 at screening
  • Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

  • Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
  • Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
  • Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
  • History of acute or chronic pancreatitis
  • Severe congestive heart failure (New York Heart Association IV)
  • History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Elecoglipron (one of the studied dose levels) + dapagliflozin
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
Drug: Elecoglipron
Elecoglipron is administered orally once daily.
Drug: Dapagliflozin
Dapagliflozin administered orally once daily.
Placebo Comparator: Elecoglipron-matched placebo + dapagliflozin-matched placebo
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
Drug: Dapagliflozin-matched placebo
A placebo matching 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
Achievement of HbA1c < 7% (53 mmol/mol)
Time Frame: Week 40
Week 40
Achievement of HbA1c ≤ 6.5% (48 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
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
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 (Estimated)

July 6, 2026

Primary Completion (Estimated)

July 14, 2028

Study Completion (Estimated)

July 14, 2028

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

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

Other Study ID Numbers

  • D7261C00002
  • 2025-523936-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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