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 (Eluminate-2)
Status and phase
Begins enrollment this month
Phase 3
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: Elecoglipron
Drug: Semaglutide
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).
Enrollment
1,200 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,200 participants in 2 patient groups
Elecoglipron
Experimental group
Description:
Participants will receive elecoglipron dose XX mg administered orally once daily.
Treatment:
Drug: Elecoglipron
Semaglutide
Active Comparator group
Description:
Participants will receive semaglutide dose XX mg administered orally once daily.
Treatment:
Drug: Semaglutide
Trial contacts and locations
158
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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