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)

June 18, 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

Not yet 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

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
      • Rosario, Argentina, S2000CVD
        • Research Site
      • San Nicolás, Argentina, B2900DMH
        • Research Site
      • San Vicente, Argentina, 5006
        • Research Site
  • Australia
      • East Toowoomba, Australia, 4350
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • Parkville, Australia, 3050
        • Research Site
      • St Leonards, Australia, 2065
        • Research Site
  • Brazil
      • Brasília, Brazil, 71625-009
        • Research Site
      • Campinas, Brazil, 13060-904
        • Research Site
      • Curitiba, Brazil, 80030-480
        • Research Site
      • Natal, Brazil, 59020-035
        • Research Site
      • Porto Alegre, Brazil, 90630-165
        • Research Site
      • São José dos Campos, Brazil, 12243-280
        • Research Site
      • São Paulo, Brazil, 04012-180
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1618
        • Research Site
      • Sofia, Bulgaria, 1700
        • Research Site
      • Yambol, Bulgaria, 8600
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Research Site
      • Stouffville, Ontario, Canada, L4A1H2
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • Research Site
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Research Site
  • China
      • Changsha, China, 410013
        • Research Site
      • Changsha, China, 410015
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Huai'an, China, 223005
        • Research Site
      • Liangyugang, China, 222002
        • Research Site
      • Nanjing, China, 2100008
        • Research Site
      • Nanyang, China, 473009
        • Research Site
      • Pingxiang, China, 337055
        • Research Site
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Research Site
      • Berlin, Germany, 13597
        • Research Site
      • Chemnitz, Germany, 09116
        • Research Site
      • Damme, Germany, 49401
        • Research Site
      • Duisburg, Germany, 47051
        • Research Site
      • Elsterwerda, Germany, 04910
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Essen, Germany, 45359
        • Research Site
      • Falkensee, Germany, 14612
        • Research Site
      • Gladbeck, Germany, 45968
        • Research Site
      • Hamburg, Germany, 21109
        • Research Site
      • Hamburg, Germany, 22607
        • Research Site
      • Leipzig, Germany, 04249
        • Research Site
      • Mannheim, Germany, 68167
        • Research Site
      • Münster, Germany, 48145
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Pirna, Germany, 01796
        • Research Site
      • Sankt Ingbert, Germany, 66386
        • Research Site
      • Wangen, Germany, 88239
        • 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
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Chieti, Italy, 66100
        • Research Site
      • Milan, Italy, 20138
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Modena, Italy, 41100
        • Research Site
      • Naples, Italy, 80138
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma, Italy, 00161
        • Research Site
  • Japan
      • Asahikawa-shi, Japan, 070-8530
        • Research Site
      • Chūōku, Japan, 103-0002
        • Research Site
      • Kamakura-shi, Japan, 247-0056
        • Research Site
      • Koga-shi, Japan, 306-0232
        • Research Site
      • Mito, Japan, 310-0826
        • Research Site
      • Miyazaki, Japan, 880-0034
        • Research Site
      • Nagoya, Japan, 468-0009
        • Research Site
      • Naka, Japan, 311-0113
        • Research Site
  • Poland
      • Bialystok, Poland, 15-897
        • Research Site
      • Krakow, Poland, 31-261
        • 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
  • South Korea
      • Daegu, South Korea, 41404
        • Research Site
      • Daejeon, South Korea, 35015
        • Research Site
      • Guri-si, South Korea, 11923
        • Research Site
      • Incheon, South Korea, 21565
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 05278
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Research Site
      • Kaohsiung City, Taiwan, 81362
        • 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, 704
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
      • Yung Kang City, Taiwan, 71044
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Research Site
      • Banbury, United Kingdom, OX16 9AD
        • Research Site
      • Bristol, United Kingdom, BS34 6BQ
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Hounslow, United Kingdom, TW3 3LN
        • Research Site
      • Penzance, United Kingdom, TR18 3DX
        • Research Site
      • Poole, United Kingdom, BH16 5PW
        • Research Site
      • Soham, United Kingdom, CB7 5JD
        • Research Site
      • Wansford, United Kingdom, PE8 6PL
        • Research Site
      • Yate, United Kingdom, BS37 4AX
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Research Site
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Research Site
      • Phoenix, Arizona, United States, 85016
        • Research Site
      • Tempe, Arizona, United States, 85281
        • Research Site
    • California
      • Encinitas, California, United States, 92024
        • Research Site
      • Garden Grove, California, United States, 92844
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Loma Linda, California, United States, 92350
        • Research Site
      • Pomona, California, United States, 91768
        • Research Site
    • Florida
      • Crystal River, Florida, United States, 34429
        • Research Site
      • Hollywood, Florida, United States, 33021
        • Research Site
      • Jacksonville, Florida, United States, 32209
        • Research Site
      • Leesburg, Florida, United States, 34748
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Research Site
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Research Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Research Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Research Site
    • Michigan
      • Southfield, Michigan, United States, 48076
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Kansas City, Missouri, United States, 64114
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89128
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87112
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Statesville, North Carolina, United States, 28625
        • Research Site
      • Wilmington, North Carolina, United States, 28403
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Sugar Land, Texas, United States, 77478
        • Research Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Research Site
      • Salt Lake City, Utah, United States, 84124
        • Research Site
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Research Site
      • Seattle, Washington, United States, 98105
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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(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
Experimental: Elecoglipron
Participants will receive elecoglipron dose XX mg administered orally once daily.
Drug: Elecoglipron
Elecoglipron is administered orally once daily.
Active Comparator: Semaglutide
Participants will receive semaglutide dose XX mg administered orally once daily.
Drug: Semaglutide
Semaglutide is 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 52
Baseline to Week 52

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
Change from baseline to Week 52 in body weight (kg)
Time Frame: Baseline to Week 52
Baseline to Week 52
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
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
Time Frame: Week 52
Week 52
Achieved HbA1c < 7% (53 mmol/mol) at Week 52
Time Frame: Week 52
Week 52
Achieved ≥ 5% weight loss from baseline at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
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

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)

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)

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

  • D7261C00005
  • 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.

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