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
132
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
132 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 8, 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
August 4, 2026
July 1, 2026
1.9 years
June 18, 2026
August 3, 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 (132)
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Sacramento, California, 95821, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
DeLand, Florida, 32720, United States
Research Site
Doral, Florida, 33166, United States
Research Site
Ocoee, Florida, 34761, United States
Research Site
Decatur, Georgia, 30030, United States
Research Site
Potomac, Maryland, 20854, United States
Research Site
Brooklyn, New York, 11220, United States
Research Site
Cary, North Carolina, 27518, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Myrtle Beach, South Carolina, 29572, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Houston, Texas, 77040, United States
Research Site
Round Rock, Texas, 78681, United States
Research Site
San Antonio, Texas, 78231, United States
Research Site
Renton, Washington, 98057, United States
Research Site
Campbelltown, 2560, Australia
Research Site
East Toowoomba, 4350, Australia
Research Site
Heidelberg Heights, 3081, Australia
Research Site
Parkville, 3050, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Dupnitsa, 2600, Bulgaria
Research Site
Kozloduy, 3320, Bulgaria
Research Site
Plovdiv, 4001, Bulgaria
Research Site
Sofia, 1618, Bulgaria
Research Site
Stara Zagora, 6000, Bulgaria
Research Site
Veliko Tarnovo, 5000, Bulgaria
Research Site
Yambol, 8600, Bulgaria
Research Site
Surrey, British Columbia, V3T 4G8, Canada
Research Site
Vancouver, British Columbia, V5Y 3W2, Canada
Research Site
Brampton, Ontario, L6S 0C6, Canada
Research Site
North York, Ontario, M6B 3H7, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Scarborough Village, Ontario, M1R 0B1, Canada
Research Site
Toronto, Ontario, M4G3E8, Canada
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Research Site
Changsha, 410013, China
Research Site
Changsha, 410015, China
Research Site
Hefei, 230000, China
Research Site
Hefei, 230601, China
Research Site
Huai'an, 223005, China
Research Site
Langfang, 065000, China
Research Site
Liangyugang, 222002, China
Research Site
Luoyang, 471009, China
Research Site
Nanjing, 2100008, China
Research Site
Nanyang, 473009, China
Research Site
Pinggu, 101200, China
Research Site
Pingxiang, 337055, China
Research Site
Shijiazhuang, 050000, China
Research Site
Tianjin, 300134, China
Research Site
Yueyang, 414000, China
Research Site
Broumov, 55001, Czechia
Research Site
České Budějovice, 370 01, Czechia
Research Site
Ostrava, 710 00, Czechia
Research Site
Pilsen, 301 00, Czechia
Research Site
Prague, 140 00, Czechia
Research Site
Prague, 170 00, Czechia
Research Site
Prague, 181 00, Czechia
Research Site
Amberg, 92224, Germany
Research Site
Bad Oeynhausen, 32545, Germany
Research Site
Berlin, 13597, Germany
Research Site
Bochum, 44869, Germany
Research Site
Brandenburg an der Havel, 14776, Germany
Research Site
Daaden, 57567, Germany
Research Site
Duisburg, 47051, Germany
Research Site
Eisenach, 99817, Germany
Research Site
Elsterwerda, 04910, Germany
Research Site
Falkensee, 14612, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Fulda, 36037, Germany
Research Site
Gladbeck, 45968, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Hannoversch Münden, 34346, Germany
Research Site
Magdeburg, 39120, Germany
Research Site
Mannheim, 68167, Germany
Research Site
Münster, 48153, Germany
Research Site
Nittendorf, 93152, Germany
Research Site
Obertshausen, 63179, Germany
Research Site
Oldenburg, 23758, Germany
Research Site
Pirna, 01796, Germany
Research Site
Bangalore, 560 092, India
Research Site
Belagavi, 590006, India
Research Site
Chennai, 600086, India
Research Site
Coimbatore, 641018, India
Research Site
Guntur, 522001, India
Research Site
Hyderabad, 500034, India
Research Site
Indore, 452008, India
Research Site
Kochi, 682041, India
Research Site
Madurai, 625020, India
Research Site
Mumbai, 400012, India
Research Site
New Delhi, 110029, India
Research Site
Pune, 411021, India
Research Site
Asahikawa-shi, 070-8530, Japan
Research Site
Kamakura-shi, 247-0056, Japan
Research Site
Kashiwa-shi, 277-0825, Japan
Research Site
Kobe, 650-0047, Japan
Research Site
Komoro, 384-8588, Japan
Research Site
Kumamoto, 862-0976, Japan
Research Site
Kyoto, 606-8507, Japan
Research Site
Miyazaki, 880-0034, Japan
Research Site
Naka, 311-0113, Japan
Research Site
Sapporo, 060-0062, Japan
Research Site
Yokohama, 230-8765, Japan
Research Site
Batu Caves, 68100, Malaysia
Research Site
Kuala Lumpur, 59100, Malaysia
Research Site
Miri, 98000, Malaysia
Research Site
Putrajaya, 62250, Malaysia
Research Site
Seremban, 70300, Malaysia
Research Site
Bialystok, 15-897, Poland
Research Site
Częstochowa, 42-217, Poland
Research Site
Kielce, 25-355, Poland
Research Site
Krakow, 31-261, Poland
Research Site
Lodz, 90-338, Poland
Research Site
Poznan, 60-354, Poland
Research Site
Radom, 26-600, Poland
Research Site
Warsaw, 00-124, Poland
Research Site
Warsaw, 02-507, Poland
Research Site
Bucheon-si, 14647, South Korea
Research Site
Gyeonggi-do, 13620, South Korea
Research Site
Jongno-gu, 110-746, South Korea
Research Site
Junggu, 22332, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Hat Yai, 90110, Thailand
Research Site
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 8, 2026
Primary Completion (Estimated)
May 23, 2028
Study Completion (Estimated)
May 23, 2028
Last Updated
August 4, 2026
Record last verified: 2026-07
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.