Eluminate-3

RecruitingPhase 3

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 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)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

132

Recruiting sites

Estimated enrollment

600

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≥23•HbA1c 7-10.5%

Primary endpoint

•Hemoglobin A1c (HbA1c)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07664553

Org study IDD7261C00006

Secondary ID2025

Secondary ID2025-523935-20-00

Timeline

Milestones

Study first posted2026-06-24actual

Study start2026-07-08actual

Last update posted2026-08-04actual

Primary completion2028-05-23estimated

Study completion2028-05-23estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Percent change from baseline to Week 40 in body weight

Time frame:Baseline to Week 40

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to Week 40 in body weight (kg)

Time frame:Baseline to Week 40

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline to Week 40

change from baseline, improvement

Secondary/protocol endpoint

Achieved HbA1c < 7% (53 mmol/mol) at Week 40

Time frame:Week 40

threshold achievement, improvement

Secondary/protocol endpoint

Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40

Time frame:Week 40

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline to Week 40 in fasting plasma glucose (FPG)

Time frame:Baseline to Week 40

change from baseline, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

Change from baseline to Week 40 in total daily insulin dose (IU)

Time frame:Baseline to Week 40

change from baseline, improvement

Secondary/protocol endpoint

Discontinued insulin by Week 40

Time frame:Baseline to Week 40

descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from baseline to Week 40 in Systolic blood pressure (SBP)

Time frame:Baseline to Week 40

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to Week 40 in diastolic blood pressure (DBP)

Time frame:Baseline to Week 40

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.