Type 2 Diabetes MellitusPhase 3Eluminate-3NCT07664553
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
A Phase 3 study testing Elecoglipron in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 132 sites in 13 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Elecoglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 132 sitesin 13 countries
- Study dates
- 8 Jul 2026to 23 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
132 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
132 sites in 13 countries
Germany22 sites, 14 recruiting
- Not yet recruiting
Research Site
Amberg, 92224
- Not yet recruiting
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Bad Oeynhausen, 32545
- Withdrawn
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Berlin, 13597
- Withdrawn
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Bochum, 44869
- Withdrawn
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Brandenburg an der Havel, 14776
- Withdrawn
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Daaden, 57567
- Not yet recruiting
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Duisburg, 47051
- Not yet recruiting
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Eisenach, 99817
- Not yet recruiting
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Elsterwerda, 04910
- Not yet recruiting
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Falkensee, 14612
- Not yet recruiting
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Frankfurt, 60596
- Withdrawn
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Fulda, 36037
- Not yet recruiting
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Gladbeck, 45968
- Not yet recruiting
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Hamburg, 22607
- Withdrawn
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Hannoversch Münden, 34346
- Not yet recruiting
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Magdeburg, 39120
- Not yet recruiting
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Mannheim, 68167
- Not yet recruiting
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Münster, 48153
- Not yet recruiting
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Nittendorf, 93152
- Not yet recruiting
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Obertshausen, 63179
- Withdrawn
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Oldenburg, 23758
- Withdrawn
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Pirna, 01796
United States17 sites, 15 recruiting
- Not yet recruiting
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Aurora, Colorado, 80045
- Suspended
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Brooklyn, New York, 11220
- Not yet recruiting
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Cary, North Carolina, 27518
- Not yet recruiting
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Decatur, Georgia, 30030
- Suspended
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DeLand, Florida, 32720
- Not yet recruiting
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Doral, Florida, 33166
- Not yet recruiting
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Houston, Texas, 77040
- Not yet recruiting
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Little Rock, Arkansas, 72205
- Not yet recruiting
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Memphis, Tennessee, 38119
- Not yet recruiting
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Morehead City, North Carolina, 28557
- Not yet recruiting
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Myrtle Beach, South Carolina, 29572
- Recruiting
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Ocoee, Florida, 34761
- Not yet recruiting
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Potomac, Maryland, 20854
- Not yet recruiting
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Renton, Washington, 98057
- Not yet recruiting
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Round Rock, Texas, 78681
- Not yet recruiting
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Sacramento, California, 95821
- Not yet recruiting
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San Antonio, Texas, 78231
China15 sites, 15 recruiting
- Not yet recruiting
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Changsha, 410013
- Not yet recruiting
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Changsha, 410015
- Not yet recruiting
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Hefei, 230000
- Not yet recruiting
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Hefei, 230601
- Not yet recruiting
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Huai'an, 223005
- Not yet recruiting
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Langfang, 065000
- Not yet recruiting
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Liangyugang, 222002
- Not yet recruiting
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Luoyang, 471009
- Not yet recruiting
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Nanjing, 2100008
- Not yet recruiting
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Nanyang, 473009
- Not yet recruiting
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Pinggu, 101200
- Not yet recruiting
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Pingxiang, 337055
- Not yet recruiting
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Shijiazhuang, 050000
- Not yet recruiting
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Tianjin, 300134
- Not yet recruiting
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Yueyang, 414000
India12 sites, 12 recruiting
- Not yet recruiting
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Bangalore, 560 092
- Not yet recruiting
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Belagavi, 590006
- Not yet recruiting
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Chennai, 600086
- Not yet recruiting
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Coimbatore, 641018
- Not yet recruiting
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Guntur, 522001
- Not yet recruiting
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Hyderabad, 500034
- Not yet recruiting
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Indore, 452008
- Not yet recruiting
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Kochi, 682041
- Not yet recruiting
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Madurai, 625020
- Not yet recruiting
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Mumbai, 400012
- Not yet recruiting
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New Delhi, 110029
- Not yet recruiting
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Pune, 411021
Japan11 sites, 11 recruiting
- Not yet recruiting
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Asahikawa-shi, 070-8530
- Not yet recruiting
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Kamakura-shi, 247-0056
- Not yet recruiting
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Kashiwa-shi, 277-0825
- Not yet recruiting
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Kobe, 650-0047
- Not yet recruiting
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Komoro, 384-8588
- Not yet recruiting
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Kumamoto, 862-0976
- Not yet recruiting
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Kyoto, 606-8507
- Recruiting
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Miyazaki, 880-0034
- Recruiting
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Naka, 311-0113
- Not yet recruiting
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Sapporo, 060-0062
- Not yet recruiting
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Yokohama, 230-8765
Poland9 sites, 8 recruiting
- Not yet recruiting
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Bialystok, 15-897
- Not yet recruiting
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Częstochowa, 42-217
- Not yet recruiting
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Kielce, 25-355
- Withdrawn
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Krakow, 31-261
- Not yet recruiting
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Lodz, 90-338
- Not yet recruiting
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Poznan, 60-354
- Not yet recruiting
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Radom, 26-600
- Not yet recruiting
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Warsaw, 00-124
- Not yet recruiting
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Warsaw, 02-507
Canada8 sites, 8 recruiting
- Not yet recruiting
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Brampton, Ontario, L6S 0C6
- Not yet recruiting
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North York, Ontario, M6B 3H7
- Not yet recruiting
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Saint-Charles-Borromée, Quebec, J6E 2B4
- Not yet recruiting
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Sarnia, Ontario, N7T 4X3
- Not yet recruiting
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Scarborough Village, Ontario, M1R 0B1
- Not yet recruiting
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Surrey, British Columbia, V3T 4G8
- Recruiting
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Toronto, Ontario, M4G3E8
- Recruiting
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Vancouver, British Columbia, V5Y 3W2
South Korea8 sites, 8 recruiting
- Not yet recruiting
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Bucheon-si, 14647
- Not yet recruiting
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Gyeonggi-do, 13620
- Not yet recruiting
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Jongno-gu, 110-746
- Not yet recruiting
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Junggu, 22332
- Not yet recruiting
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Seoul, 03080
- Not yet recruiting
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Seoul, 03722
- Not yet recruiting
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Seoul, 06591
- Not yet recruiting
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Seoul, 5505
Bulgaria7 sites, 7 recruiting
- Not yet recruiting
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Dupnitsa, 2600
- Not yet recruiting
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Kozloduy, 3320
- Not yet recruiting
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Plovdiv, 4001
- Not yet recruiting
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Sofia, 1618
- Not yet recruiting
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Stara Zagora, 6000
- Not yet recruiting
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Veliko Tarnovo, 5000
- Not yet recruiting
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Yambol, 8600
Czechia7 sites, 7 recruiting
- Not yet recruiting
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Broumov, 55001
- Not yet recruiting
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České Budějovice, 370 01
- Not yet recruiting
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Ostrava, 710 00
- Not yet recruiting
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Pilsen, 301 00
- Not yet recruiting
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Prague, 140 00
- Not yet recruiting
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Prague, 170 00
- Not yet recruiting
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Prague, 181 00
Thailand6 sites, 6 recruiting
- Not yet recruiting
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Bangkok, 10330
- Not yet recruiting
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Bangkok, 10400
- Not yet recruiting
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Bangkok, 10700
- Not yet recruiting
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Hat Yai, 90110
- Not yet recruiting
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Muang, 50200
- Not yet recruiting
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Mueang, 20000
Australia5 sites, 5 recruiting
- Not yet recruiting
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Campbelltown, 2560
- Recruiting
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East Toowoomba, 4350
- Not yet recruiting
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Heidelberg Heights, 3081
- Not yet recruiting
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Parkville, 3050
- Not yet recruiting
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St Leonards, 2065
Malaysia5 sites, 5 recruiting
- Not yet recruiting
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Batu Caves, 68100
- Not yet recruiting
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Kuala Lumpur, 59100
- Not yet recruiting
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Miri, 98000
- Not yet recruiting
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Putrajaya, 62250
- Not yet recruiting
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Seremban, 70300
About this study
Official title: 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)
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Elecoglipron, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Elecoglipron is administered orally once daily.
PlaceboDrug
Placebo is administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Elecoglipron dose level 1 | Experimental | Participants will receive elecoglipron at dose level 1 administered orally once daily. Receives: Drug: Elecoglipron |
| Elecoglipron dose level 2 | Experimental | Participants will receive elecoglipron at dose level 2 administered orally once daily. Receives: Drug: Elecoglipron |
| Placebo | Placebo comparator | Participants will receive placebo administered orally once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hemoglobin A1c (HbA1c)
Summary statistics
Measured: Baseline to Week 40
Secondary outcomes (11)
Achieved HbA1c < 7% (53 mmol/mol) at Week 40
Measured: Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40
Measured: Week 40
Percent change from baseline to Week 40 in body weight
Measured: Baseline to Week 40
Change from baseline to Week 40 in body weight (kg)
Measured: Baseline to Week 40
Change from baseline to Week 40 in Systolic blood pressure (SBP)
Measured: Baseline to Week 40
Change from baseline to Week 40 in fasting plasma glucose (FPG)
Measured: 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)
Measured: Baseline to Week 40
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)
Measured: Baseline to Week 40
Change from baseline to Week 40 in diastolic blood pressure (DBP)
Measured: Baseline to Week 40
Change from baseline to Week 40 in total daily insulin dose (IU)
Measured: Baseline to Week 40
Discontinued insulin by Week 40
Measured: Baseline to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start8 Jul 2026
- Primary completion23 May 2028 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664553
- Sponsor's protocol ID
- D7261C00006
- Other IDs
- 2025-523935-20-00, 2025
- Acronym
- Eluminate-3
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07664553
- Acronym / sponsor ID
- Eluminate-3 / D7261C00006
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 23 May 2028 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elecoglipron dose level 1 | Experimental | Drug: ElecoglipronParticipants will receive elecoglipron at dose level 1 administered orally once daily. |
| Elecoglipron dose level 2 | Experimental | Drug: ElecoglipronParticipants will receive elecoglipron at dose level 2 administered orally once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo administered orally once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElecoglipronElecoglipron is administered orally once daily. | Drug | Elecoglipron dose level 1, Elecoglipron dose level 2 |
| PlaceboPlacebo is administered orally once daily. | Drug | Placebo |
Primary outcome
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 40
Summary statistics
11 secondary outcomes
Achieved HbA1c < 7% (53 mmol/mol) at Week 40
Time frame: Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40
Time frame: Week 40
Percent change from baseline to Week 40 in body weight
Time frame: Baseline to Week 40
Change from baseline to Week 40 in body weight (kg)
Time frame: Baseline to Week 40
Change from baseline to Week 40 in Systolic blood pressure (SBP)
Time frame: Baseline to Week 40
Change from baseline to Week 40 in fasting plasma glucose (FPG)
Time frame: 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
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)
Time frame: Baseline to Week 40
Change from baseline to Week 40 in diastolic blood pressure (DBP)
Time frame: Baseline to Week 40
Change from baseline to Week 40 in total daily insulin dose (IU)
Time frame: Baseline to Week 40
Discontinued insulin by Week 40
Time frame: Baseline to Week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
132 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elecoglipron in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 132 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in Germany, United States, China, India, Japan and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.