This study is a multicenter, randomized, open-label, parallel-group, semaglutide injection-controlled clinical trial. It aims to evaluate the non-inferiority of UBT251 Injection in glycemic control compared with Semaglutide Injection after 36 weeks of continuous administration in study participants with Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control on oral antidiabetic medications.A total of 956 participants are planned to be enrolled, including the UBT251 Injection 2 mg group, 4 mg group, 6 mg group, and Semaglutide group，with an approximate study duration of 58 weeks per participant.
Aged 18 to 75 years (inclusive) at the time of signing informed consent, with no restriction on gender;
Diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the 2019 World Health Organization (WHO) criteria (Appendix 1), with glycated hemoglobin (HbA1c) ≥7.5% and ≤11.0%;
Body mass index (BMI) ≥23.0 kg/m² at screening, with stable body weight for 3 months prior to screening (change <5%, based on participant's report);
Participants (including their partners) with no plan for pregnancy from screening until 6 months after completion of the study, willing to use contraceptive measures, and with no plan to donate sperm or ova within 6 months after study completion;
Known history of hypersensitivity to the investigational medicinal product or its excipients or other similar active drugs;
Other antidiabetic medications except background therapy (short-term insulin use ≤14 days for acute conditions is allowed, e.g., perioperative period or hospitalization);
Medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (excluded if cumulative use <7 days and the end of treatment is >7 half-lives prior to the first day of screening);
Weight-loss medications (including but not limited to orlistat, semaglutide, or other similar prescription or over-the-counter drugs for weight loss).