Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Prior treatment

• Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
• Received medication for weight loss within the last 3 months prior to screening.
• Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).

Other illness

• Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.
• History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.
• History of acute or chronic pancreatitis.

• Adults ≥ 18 years of age.
• Diagnosed with T2DM for at least 6 months.
• HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.
• Body mass index of ≥ 23 kg/m2.
• Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).