Phase 2 Study of HRS9531 Tablets for Adults Aged 18 to 70 With Type 2 Diabetes Mellitus to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the efficacy and safety of HRS9531 tablets compared to a placebo in adults with type 2 diabetes mellitus who have not achieved adequate blood sugar control through lifestyle changes alone or a stable dose of metformin. This phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to provide important information about this new treatment option. The trial is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and will last 20 weeks. Participants will be randomly assigned to one of several groups receiving different doses of HRS9531 tablets or a placebo. The study uses a triple-blind design to ensure unbiased results. Treatments will be administered orally, and participants will follow the assigned dosing schedule throughout the 20-week treatment period. This parallel-group study evaluates multiple doses against placebo to assess how well the drug works and its safety. During the study, participants will have regular visits to monitor changes in their blood sugar levels, including glycated hemoglobin HbA1c, fasting plasma glucose, and body weight. Researchers will also track any hypoglycemic events and adverse effects. Assessments will occur at baseline and through the 20 weeks of treatment. Participants will be expected to comply with all study procedures and follow-up visits to help measure treatment impact and safety.

A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus