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).
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)
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)
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
Parallel
Elecoglipron
DrugElecoglipron is administered orally once daily.
Placebo
DrugPlacebo is administered orally once daily.
Change from baseline in Hemoglobin A1c (HbA1c)
Achievement of HbA1c < 7% (53 mmol/mol)
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Percent change in body weight
Change from baseline in body weight
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