A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin
Diagnosed with T2DM for at least 90 days prior to screening
Stable treatment with background insulin and other background glucose-lowering medication(s)
HbA1c value of ≥ 7% to ≤ 10.5%
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening
You may not be if
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 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 (NYHA IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Clareo Health | A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin
