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

Inclusion Criteria

• 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:
• (a) On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
• (b) 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