Eluminate-2

Not yet recruitingPhase 3

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)

Lead sponsor

AstraZeneca

Asset

Semaglutide

GLP-1 agonist

Listed sites

158

Recruiting sites

Estimated enrollment

1,200

Study population

Obesity / overweight, 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 IDNCT07662213

Org study IDD7261C00005

Secondary ID2025-523933-24-00

Timeline

Milestones

Study first posted2026-06-23actual

Last update posted2026-06-23actual

Study start2026-07-06estimated

Primary completion2028-05-23estimated

Study completion2028-05-23estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening

•T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)

•HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)

•Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors

•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

•Type 1 Diabetes Mellitus (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 Gastrointestinal (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 (8)

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

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Percent change from baseline to Week 52 in body weight

Time frame:Baseline to Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to Week 52 in body weight (kg)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52

Time frame:Baseline to Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Achieved ≥ 5% weight loss from baseline at Week 52

Time frame:Baseline to Week 52

threshold achievement, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Achieved HbA1c < 7% (53 mmol/mol) at Week 52

Time frame:Week 52

threshold achievement, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP

Time frame:Baseline to Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 July 6, 2026 snapshot.