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Clinical Trial Β· PHASE3 Β· Recruiting

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

07 September 2026 NCT07662135 ClinicalTrials.gov β†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
18 Years+

About This Trial

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).

Who Can Join?

Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening * On SGTL2i or SGLT2i-naΓ―ve and other glucose lowering medication(s) * HbA1c value: 1. On stable dose of SGLT2i β‰₯ 7.0 % to ≀ 10.5% (53 to 91.3 mmol/mol) 2. SGLT2i-naive β‰₯ 7.5% to ≀ 10.5% (58 to 91.3 mmol/mol) * Impaired renal function * Body mass index (BMI) of β‰₯ 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 *…

⚠ Always speak to your doctor before applying to any clinical trial.

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