A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

August 3, 2026 updated by: AstraZeneca

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

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

  • Australia
      • Campbelltown, Australia, 2560
        • Not yet recruiting
        • Research Site
      • East Toowoomba, Australia, 4350
        • Recruiting
        • Research Site
      • Heidelberg Heights, Australia, 3081
        • Not yet recruiting
        • Research Site
      • Parkville, Australia, 3050
        • Not yet recruiting
        • Research Site
      • St Leonards, Australia, 2065
        • Not yet recruiting
        • Research Site
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Not yet recruiting
        • Research Site
      • Kozloduy, Bulgaria, 3320
        • Not yet recruiting
        • Research Site
      • Plovdiv, Bulgaria, 4001
        • Not yet recruiting
        • Research Site
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • Research Site
      • Stara Zagora, Bulgaria, 6000
        • Not yet recruiting
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Not yet recruiting
        • Research Site
      • Yambol, Bulgaria, 8600
        • Not yet recruiting
        • Research Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 4G8
        • Not yet recruiting
        • Research Site
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Recruiting
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Not yet recruiting
        • Research Site
      • North York, Ontario, Canada, M6B 3H7
        • Not yet recruiting
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Not yet recruiting
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Not yet recruiting
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Recruiting
        • Research Site
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Not yet recruiting
        • Research Site
  • China
      • Changsha, China, 410013
        • Not yet recruiting
        • Research Site
      • Changsha, China, 410015
        • Not yet recruiting
        • Research Site
      • Hefei, China, 230601
        • Not yet recruiting
        • Research Site
      • Hefei, China, 230000
        • Not yet recruiting
        • Research Site
      • Huai'an, China, 223005
        • 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
      • Nanjing, China, 2100008
        • 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
      • Shijiazhuang, China, 050000
        • Not yet recruiting
        • Research Site
      • Tianjin, China, 300134
        • Not yet recruiting
        • Research Site
      • Yueyang, China, 414000
        • Not yet recruiting
        • Research Site
  • Czechia
      • Broumov, Czechia, 55001
        • Not yet recruiting
        • Research Site
      • Ostrava, Czechia, 710 00
        • Not yet recruiting
        • Research Site
      • Pilsen, Czechia, 301 00
        • Not yet recruiting
        • Research Site
      • Prague, Czechia, 140 00
        • Not yet recruiting
        • Research Site
      • Prague, Czechia, 170 00
        • Not yet recruiting
        • Research Site
      • Prague, Czechia, 181 00
        • Not yet recruiting
        • Research Site
      • České Budějovice, Czechia, 370 01
        • Not yet recruiting
        • Research Site
  • Germany
      • Amberg, Germany, 92224
        • Not yet recruiting
        • Research Site
      • Bad Oeynhausen, Germany, 32545
        • Not yet recruiting
        • Research Site
      • Berlin, Germany, 13597
        • Withdrawn
        • Research Site
      • Bochum, Germany, 44869
        • Withdrawn
        • Research Site
      • Brandenburg an der Havel, Germany, 14776
        • Withdrawn
        • Research Site
      • Daaden, Germany, 57567
        • Withdrawn
        • Research Site
      • Duisburg, Germany, 47051
        • Not yet recruiting
        • Research Site
      • Eisenach, Germany, 99817
        • Not yet recruiting
        • Research Site
      • Elsterwerda, Germany, 04910
        • Not yet recruiting
        • Research Site
      • Falkensee, Germany, 14612
        • Not yet recruiting
        • Research Site
      • Frankfurt, Germany, 60596
        • Not yet recruiting
        • Research Site
      • Fulda, Germany, 36037
        • Withdrawn
        • Research Site
      • Gladbeck, Germany, 45968
        • Not yet recruiting
        • Research Site
      • Hamburg, Germany, 22607
        • Not yet recruiting
        • Research Site
      • Hannoversch Münden, Germany, 34346
        • Withdrawn
        • Research Site
      • Magdeburg, Germany, 39120
        • Not yet recruiting
        • Research Site
      • Mannheim, Germany, 68167
        • Not yet recruiting
        • Research Site
      • Münster, Germany, 48153
        • Not yet recruiting
        • Research Site
      • Nittendorf, Germany, 93152
        • Not yet recruiting
        • Research Site
      • Obertshausen, Germany, 63179
        • Not yet recruiting
        • Research Site
      • Oldenburg, Germany, 23758
        • Withdrawn
        • Research Site
      • Pirna, Germany, 01796
        • Withdrawn
        • Research Site
  • India
      • Bangalore, India, 560 092
        • Not yet recruiting
        • Research Site
      • Belagavi, India, 590006
        • Not yet recruiting
        • Research Site
      • Chennai, India, 600086
        • Not yet recruiting
        • Research Site
      • Coimbatore, India, 641018
        • Not yet recruiting
        • Research Site
      • Guntur, India, 522001
        • Not yet recruiting
        • Research Site
      • Hyderabad, India, 500034
        • Not yet recruiting
        • Research Site
      • Indore, India, 452008
        • Not yet recruiting
        • Research Site
      • Kochi, India, 682041
        • Not yet recruiting
        • Research Site
      • Madurai, India, 625020
        • Not yet recruiting
        • Research Site
      • Mumbai, India, 400012
        • Not yet recruiting
        • Research Site
      • New Delhi, India, 110029
        • Not yet recruiting
        • Research Site
      • Pune, India, 411021
        • Not yet recruiting
        • Research Site
  • Japan
      • Asahikawa-shi, Japan, 070-8530
        • Not yet recruiting
        • Research Site
      • Kamakura-shi, Japan, 247-0056
        • Not yet recruiting
        • Research Site
      • Kashiwa-shi, Japan, 277-0825
        • Not yet recruiting
        • Research Site
      • Kobe, Japan, 650-0047
        • Not yet recruiting
        • Research Site
      • Komoro, Japan, 384-8588
        • Not yet recruiting
        • Research Site
      • Kumamoto, Japan, 862-0976
        • Not yet recruiting
        • Research Site
      • Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Research Site
      • Miyazaki, Japan, 880-0034
        • Recruiting
        • Research Site
      • Naka, Japan, 311-0113
        • Recruiting
        • Research Site
      • Sapporo, Japan, 060-0062
        • Not yet recruiting
        • Research Site
      • Yokohama, Japan, 230-8765
        • Not yet recruiting
        • Research Site
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Not yet recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Not yet recruiting
        • Research Site
      • Miri, Malaysia, 98000
        • Not yet recruiting
        • Research Site
      • Putrajaya, Malaysia, 62250
        • Not yet recruiting
        • Research Site
      • Seremban, Malaysia, 70300
        • 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
      • Krakow, Poland, 31-261
        • Withdrawn
        • Research Site
      • Lodz, Poland, 90-338
        • 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
  • South Korea
      • Bucheon-si, South Korea, 14647
        • Not yet recruiting
        • Research Site
      • Gyeonggi-do, South Korea, 13620
        • Not yet recruiting
        • Research Site
      • Jongno-gu, South Korea, 110-746
        • Not yet recruiting
        • Research Site
      • Junggu, South Korea, 22332
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Not yet recruiting
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Research Site
      • Bangkok, Thailand, 10330
        • Not yet recruiting
        • Research Site
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Research Site
      • Hat Yai, Thailand, 90110
        • Not yet recruiting
        • Research Site
      • Muang, Thailand, 50200
        • Not yet recruiting
        • Research Site
      • Mueang, Thailand, 20000
        • Not yet recruiting
        • Research Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • Research Site
    • California
      • Sacramento, California, United States, 95821
        • Not yet recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Research Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Suspended
        • Research Site
      • Doral, Florida, United States, 33166
        • Not yet recruiting
        • Research Site
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Research Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Not yet recruiting
        • Research Site
    • Maryland
      • Potomac, Maryland, United States, 20854
        • Not yet recruiting
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11220
        • Suspended
        • Research Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Not yet recruiting
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Not yet recruiting
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Not yet recruiting
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Not yet recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77040
        • Not yet recruiting
        • Research Site
      • Round Rock, Texas, United States, 78681
        • Not yet recruiting
        • Research Site
      • San Antonio, Texas, United States, 78231
        • Not yet recruiting
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • 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

No

Description

Inclusion Criteria:

  • Diagnosed with T2DM for at least 90 days prior to screening
  • Stable treatment with background insulin and other background glucose-lowering medication(s)
  • HbA1c value of ≥ 7% to ≤ 10.5%
  • 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:

  • 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 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elecoglipron dose level 1
Participants will receive elecoglipron at dose level 1 administered orally once daily.
Drug: Elecoglipron
Elecoglipron is administered orally once daily.
Experimental: Elecoglipron dose level 2
Participants will receive elecoglipron at dose level 2 administered orally once daily.
Drug: Elecoglipron
Elecoglipron is administered orally once daily.
Placebo Comparator: Placebo
Participants will receive placebo administered orally once daily.
Drug: Placebo
Placebo is administered orally once daily.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Achieved HbA1c < 7% (53 mmol/mol) at Week 40
Time Frame: Week 40
Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40
Time Frame: Week 40
Week 40
Percent change from baseline to Week 40 in body weight
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in body weight (kg)
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in Systolic blood pressure (SBP)
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in fasting plasma glucose (FPG)
Time Frame: Baseline to Week 40
Baseline to Week 40
Achieved HbA1c < 7% (53 mmol/mol) at Week 40 without hypoglycemia (glucose < 54 mg/dL [3.0 mmol/L] or severe hypoglycemia)
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in diastolic blood pressure (DBP)
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in total daily insulin dose (IU)
Time Frame: Baseline to Week 40
Baseline to Week 40
Discontinued insulin by Week 40
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 8, 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 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7261C00006
  • 2025-523935-20-00 (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.

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.

Subscribe