The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.
Male or female, aged 18 to 70 years on the day of signing the informed consent form;
Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);
HbA1c between 7.5% and 10.5% at screening;
Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;
Participants with relevant abnormal test results at screening.
Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.
Participants with poorly controlled blood pressure.
Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.
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Treatment groupsSee each treatment group below.