Elecoglipron for adults with type 2 diabetes and reduced kidney function taking dapagliflozin

Trial details

Who runs it

AstraZeneca

Trial code

NCT07662135EU 2025-523940-12-00

Record updated

2 September 2026

Original description

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).Read full original descriptionShow less

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

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).

Inclusion: 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:; On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol); 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: 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; Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma; 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.

ClinicalTrials.gov NCT07662135 · EU CTIS 2025-523940-12-00