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

A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

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.