Elecoglipron for adults with type 2 diabetes and reduced kidney function taking dapagliflozin
Tests elecoglipron against placebo in adults with type 2 diabetes and kidney problems.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Aarhus N, Gistrup, Herlev, Hilleroed, Holbæk, and Hvidovre, DenmarkSee the 6 sites
- Phase
- Phase 3
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkNot yet recruiting
- Aalborg University HospitalGistrup, DenmarkNot yet recruiting
- Steno Diabetes Center CopenhagenHerlev, DenmarkNot yet recruiting
- Region HovedstadenHilleroed, DenmarkNot yet recruiting
- Holbaek SygehusHolbæk, DenmarkNot yet recruiting
- Region HovedstadenHvidovre, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.