A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Inclusion Criteria: 1. Diagnosed with type 2 diabetes ≥ 90 days； 2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding. Exclusion Criteria: 1. Known or suspected allergy or intolerance to the investigational medicinal products or related products； 2. Acute complications of diabetes occurred during the previous 6 months； 3. Serious chronic complications of diabetes in the past； 4. Use other antidiabetic drugs for ≥3months prior to screening ; 5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.