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)

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: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Elecoglipron; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 600
• 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

• Australia
  • East Toowoomba, Australia, 4350
    • Research Site
  • Parkville, Australia, 3050
    • Research Site
  • St Leonards, Australia, 2065
    • Research Site
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Kozloduy, Bulgaria, 3320
    • Research Site
  • Plovdiv, Bulgaria, 4001
    • Research Site
  • Sofia, Bulgaria, 1618
    • Research Site
  • Stara Zagora, Bulgaria, 6000
    • Research Site
  • Veliko Tarnovo, Bulgaria, 5000
    • Research Site
  • Yambol, Bulgaria, 8600
    • Research Site
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 4G8
      • Research Site
    • Vancouver, British Columbia, Canada, V5Y 3W2
      • Research Site
  • Ontario
    • Sarnia, Ontario, Canada, N7T 4X3
      • Research Site
    • Scarborough Village, Ontario, Canada, M1R 0B1
      • Research Site
    • Toronto, Ontario, Canada, M4G3E8
      • Research Site
  • Quebec
    • 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
  • Hefei, China, 230000
    • Research Site
  • Huai'an, China, 223005
    • Research Site
  • Langfang, China, 065000
    • Research Site
  • Liangyugang, China, 222002
    • Research Site
  • Luoyang, China, 471009
    • Research Site
  • Nanjing, China, 2100008
    • Research Site
  • Nanyang, China, 473009
    • Research Site
  • Pinggu, China, 101200
    • Research Site
  • Pingxiang, China, 337055
    • Research Site
  • Shijiazhuang, China, 050000
    • Research Site
  • Tianjin, China, 300134
    • Research Site
  • Yueyang, China, 414000
    • Research Site
• Czechia
  • Broumov, Czechia, 55001
    • Research Site
  • Ostrava, Czechia, 710 00
    • Research Site
  • Pilsen, Czechia, 301 00
    • Research Site
  • Prague, Czechia, 140 00
    • Research Site
  • Prague, Czechia, 170 00
    • Research Site
  • Prague, Czechia, 181 00
    • Research Site
  • České Budějovice, Czechia, 370 01
    • Research Site
• Germany
  • Amberg, Germany, 92224
    • Research Site
  • Bad Oeynhausen, Germany, 32545
    • Research Site
  • Berlin, Germany, 13597
    • Research Site
  • Bochum, Germany, 44869
    • Research Site
  • Brandenburg an der Havel, Germany, 14776
    • Research Site
  • Daaden, Germany, 57567
    • Research Site
  • Duisburg, Germany, 47051
    • Research Site
  • Eisenach, Germany, 99817
    • Research Site
  • Elsterwerda, Germany, 04910
    • Research Site
  • Falkensee, Germany, 14612
    • Research Site
  • Frankfurt, Germany, 60596
    • Research Site
  • Fulda, Germany, 36037
    • Research Site
  • Gladbeck, Germany, 45968
    • Research Site
  • Hamburg, Germany, 22607
    • Research Site
  • Hannoversch Münden, Germany, 34346
    • Research Site
  • Magdeburg, Germany, 39120
    • Research Site
  • Mannheim, Germany, 68167
    • Research Site
  • Münster, Germany, 48153
    • Research Site
  • Nittendorf, Germany, 93152
    • Research Site
  • Obertshausen, Germany, 63179
    • Research Site
  • Oldenburg, Germany, 23758
    • Research Site
  • Pirna, Germany, 01796
    • Research Site
• India
  • Bangalore, India, 560 092
    • Research Site
  • Belagavi, India, 590006
    • Research Site
  • Chennai, India, 600086
    • Research Site
  • Coimbatore, India, 641018
    • Research Site
  • Guntur, India, 522001
    • Research Site
  • Hyderabad, India, 500034
    • Research Site
  • Indore, India, 452008
    • Research Site
  • Kochi, India, 682041
    • Research Site
  • Madurai, India, 625020
    • Research Site
  • Mumbai, India, 400012
    • Research Site
  • New Delhi, India, 110029
    • Research Site
  • Pune, India, 411021
    • Research Site
• Japan
  • Asahikawa-shi, Japan, 070-8530
    • Research Site
  • Kashiwa-shi, Japan, 277-0825
    • Research Site
  • Komoro, Japan, 384-8588
    • Research Site
  • Kyoto, Japan, 606-8507
    • Research Site
  • Miyazaki, Japan, 880-0034
    • Research Site
  • Naka, Japan, 311-0113
    • Research Site
  • Yokohama, Japan, 230-8765
    • Research Site
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Miri, Malaysia, 98000
    • Research Site
  • Putrajaya, Malaysia, 62250
    • Research Site
  • Seremban, Malaysia, 70300
    • Research Site
• Poland
  • Bialystok, Poland, 15-897
    • Research Site
  • Częstochowa, Poland, 42-217
    • Research Site
  • Kielce, Poland, 25-355
    • Research Site
  • Krakow, Poland, 31-261
    • Research Site
  • Lodz, Poland, 90-338
    • 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
  • Bucheon-si, South Korea, 14647
    • Research Site
  • Gyeonggi-do, South Korea, 13620
    • Research Site
  • Jongno-gu, South Korea, 110-746
    • Research Site
  • Junggu, South Korea, 22332
    • Research Site
  • Seoul, South Korea, 03080
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 06591
    • Research Site
  • Seoul, South Korea, 5505
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Muang, Thailand, 50200
    • Research Site
  • Mueang, Thailand, 20000
    • Research Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Lincoln, California, United States, 95648
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
  • Florida
    • Ocoee, Florida, United States, 34761
      • Research Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Research Site
  • Maryland
    • Potomac, Maryland, United States, 20854
      • Research Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Research Site
    • Morehead City, North Carolina, United States, 28557
      • Research Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Site
  • Texas
    • Houston, Texas, United States, 77040
      • Research Site
    • San Antonio, Texas, United States, 78231
      • Research Site
  • Washington
    • Renton, Washington, United States, 98057
      • Research Site

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	Summary statistics	Baseline to Week 40

Secondary Outcome Measures

Outcome Measure	Time Frame
Achieved HbA1c < 7% (53 mmol/mol) at Week 40	Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40	Week 40
Percent change from baseline to Week 40 in body weight	Baseline to Week 40
Change from baseline to Week 40 in body weight (kg)	Baseline to Week 40
Change from baseline to Week 40 in Systolic blood pressure (SBP)	Baseline to Week 40
Change from baseline to Week 40 in fasting plasma glucose (FPG)	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)	Baseline to Week 40
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)	Baseline to Week 40
Change from baseline to Week 40 in diastolic blood pressure (DBP)	Baseline to Week 40
Change from baseline to Week 40 in total daily insulin dose (IU)	Baseline to Week 40
Discontinued insulin by Week 40	Baseline to Week 40

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

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 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 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
• 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