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)
2 other identifiers
interventional
600
13 countries
120
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jul 2026
Typical duration for phase_3 type-2-diabetes-mellitus
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2028
June 24, 2026
June 1, 2026
1.9 years
June 18, 2026
June 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Hemoglobin A1c (HbA1c)
Summary statistics
Baseline to Week 40
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (3)
Elecoglipron dose level 1
EXPERIMENTALParticipants will receive elecoglipron at dose level 1 administered orally once daily.
Elecoglipron dose level 2
EXPERIMENTALParticipants will receive elecoglipron at dose level 2 administered orally once daily.
Placebo
PLACEBO COMPARATORParticipants will receive placebo administered orally once daily.
Interventions
Elecoglipron is administered orally once daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (120)
Research Site
Little Rock, Arkansas, 72205, United States
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Lincoln, California, 95648, United States
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Aurora, Colorado, 80045, United States
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Ocoee, Florida, 34761, United States
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Decatur, Georgia, 30030, United States
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Potomac, Maryland, 20854, United States
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Cary, North Carolina, 27518, United States
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Morehead City, North Carolina, 28557, United States
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Myrtle Beach, South Carolina, 29572, United States
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Memphis, Tennessee, 38119, United States
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Houston, Texas, 77040, United States
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San Antonio, Texas, 78231, United States
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Renton, Washington, 98057, United States
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East Toowoomba, 4350, Australia
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Parkville, 3050, Australia
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St Leonards, 2065, Australia
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Dupnitsa, 2600, Bulgaria
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Kozloduy, 3320, Bulgaria
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Plovdiv, 4001, Bulgaria
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Sofia, 1618, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Yambol, 8600, Bulgaria
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Surrey, British Columbia, V3T 4G8, Canada
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Vancouver, British Columbia, V5Y 3W2, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Scarborough Village, Ontario, M1R 0B1, Canada
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Toronto, Ontario, M4G3E8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Changsha, 410013, China
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Changsha, 410015, China
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Hefei, 230000, China
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Hefei, 230601, China
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Huai'an, 223005, China
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Langfang, 065000, China
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Liangyugang, 222002, China
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Luoyang, 471009, China
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Nanjing, 2100008, China
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Nanyang, 473009, China
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Pinggu, 101200, China
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Pingxiang, 337055, China
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Shijiazhuang, 050000, China
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Tianjin, 300134, China
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Yueyang, 414000, China
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Broumov, 55001, Czechia
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České Budějovice, 370 01, Czechia
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Ostrava, 710 00, Czechia
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Pilsen, 301 00, Czechia
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Prague, 140 00, Czechia
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Prague, 170 00, Czechia
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Prague, 181 00, Czechia
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Amberg, 92224, Germany
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Bad Oeynhausen, 32545, Germany
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Berlin, 13597, Germany
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Bochum, 44869, Germany
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Brandenburg an der Havel, 14776, Germany
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Daaden, 57567, Germany
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Duisburg, 47051, Germany
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Eisenach, 99817, Germany
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Elsterwerda, 04910, Germany
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Falkensee, 14612, Germany
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Frankfurt, 60596, Germany
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Fulda, 36037, Germany
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Gladbeck, 45968, Germany
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Hamburg, 22607, Germany
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Hannoversch Münden, 34346, Germany
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Magdeburg, 39120, Germany
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Mannheim, 68167, Germany
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Münster, 48153, Germany
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Nittendorf, 93152, Germany
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Obertshausen, 63179, Germany
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Oldenburg, 23758, Germany
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Pirna, 01796, Germany
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Bangalore, 560 092, India
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Belagavi, 590006, India
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Chennai, 600086, India
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Coimbatore, 641018, India
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Guntur, 522001, India
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Hyderabad, 500034, India
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Indore, 452008, India
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Kochi, 682041, India
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Madurai, 625020, India
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Mumbai, 400012, India
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New Delhi, 110029, India
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Pune, 411021, India
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Asahikawa-shi, 070-8530, Japan
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Kashiwa-shi, 277-0825, Japan
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Komoro, 384-8588, Japan
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Kyoto, 606-8507, Japan
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Miyazaki, 880-0034, Japan
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Naka, 311-0113, Japan
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Yokohama, 230-8765, Japan
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Batu Caves, 68100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Miri, 98000, Malaysia
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Putrajaya, 62250, Malaysia
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Seremban, 70300, Malaysia
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Bialystok, 15-897, Poland
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Częstochowa, 42-217, Poland
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Kielce, 25-355, Poland
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Krakow, 31-261, Poland
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Lodz, 90-338, Poland
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Poznan, 60-354, Poland
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Radom, 26-600, Poland
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Warsaw, 00-124, Poland
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Warsaw, 02-507, Poland
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Bucheon-si, 14647, South Korea
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Gyeonggi-do, 13620, South Korea
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Jongno-gu, 110-746, South Korea
Research Site
Junggu, 22332, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Seoul, 5505, South Korea
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Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
Research Site
Mueang, 20000, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 24, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
May 23, 2028
Study Completion (Estimated)
May 23, 2028
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.