The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).
Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
Type 1 Diabetes Mellitus (T1DM), 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 Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or gastric emptying
Parallel
Elecoglipron
DrugElecoglipron is administered orally once daily.
Semaglutide
DrugSemaglutide is administered orally once daily.
Change from baseline in Hemoglobin A1c (HbA1c)
Percent change from baseline to Week 52 in body weight
Change from baseline to Week 52 in body weight (kg)
Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
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