A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
Status and phase
Begins enrollment this month
Phase 3
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: Dapagliflozin-matched placebo
Drug: Elecoglipron
Drug: Elecoglipron-matched placebo
Drug: Dapagliflozin
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 and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Enrollment
2,000 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
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- 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, 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 (New York Heart Association 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
Quadruple Blind
2,000 participants in 5 patient groups
Elecoglipron dose level 1 + dapagliflozin
Experimental group
Description:
Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.
Treatment:
Drug: Dapagliflozin
Drug: Elecoglipron
Elecoglipron dose level 2 + dapagliflozin
Experimental group
Description:
Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.
Treatment:
Drug: Dapagliflozin
Drug: Elecoglipron
Elecoglipron dose level 1 + dapagliflozin-matched placebo
Experimental group
Description:
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
Treatment:
Drug: Elecoglipron
Drug: Dapagliflozin-matched placebo
Elecoglipron dose level 2 + dapagliflozin-matched placebo
Experimental group
Description:
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
Treatment:
Drug: Elecoglipron
Drug: Dapagliflozin-matched placebo
Elecoglipron-matched placebo + dapagliflozin
Active Comparator group
Description:
Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.
Treatment:
Drug: Dapagliflozin
Drug: Elecoglipron-matched placebo
Trial contacts and locations
178
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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