A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

AstraZeneca

Status and phase: Begins enrollment this month; Phase 3

Conditions: Type 2 Diabetes With Chronic Kidney Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Elecoglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07662135

D7261C00004

2025-523940-12-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)

• HbA1c value:

  1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
  2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)

• Impaired renal function

• 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

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900 participants in 3 patient groups, including a placebo group

Elecoglipron dose level 1

Experimental group

Description:

Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.

Treatment:

Drug: Elecoglipron

Elecoglipron dose level 2

Experimental group

Description:

Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.

Treatment:

Drug: Elecoglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.

Treatment:

Drug: Placebo