A Study of RAY1225 in Participants With Type 2 Diabetes

Inclusion criteria

• Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:

• have T2DM controlled with diet and exercise alone;
• are stable in dose and type on a single or in a combination of oral antidiabetic medication, metformin, α-glucosidase inhibitors or SGLT-2 inhibitors only ,within 12 weeks before screening;
• BMI ≥ 20 kg/m²；
• Fasting blood-glucose（FPG）<15 mmol/L;
• Weight change < 5% in the 12 weeks before screening;
• Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion criteria

• have type 1 diabetes mellitus；
• Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;
• Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
• had grade 3 hypoglycemic events within 12 months before screening,
• Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
• Have symptoms related to hypoglycemia at screening;
• Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;
• Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)