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: Enrolling; 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)

2025

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