A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female, able and willing to provide a written informed consent
• Diagnosed with type 2 diabetes ≥ 90 days；
• On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
• HbA1c was 7.5%\
• 0% (both inclusive);
• Body Mass Index (BMI) ≥22 kg/m2 at screening.
Locations
Other Locations
China
Perking University Peoples' Hospital
RECRUITING
Beijing
Contact Information
Primary
Hong Chen
hong.chen@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-03
Participants
Target number of participants: 300
Treatments
Experimental: Treatment group A: HRS953-low dose
Experimental: Treatment group B: HRS953-high dose
Placebo_comparator: Treatment group C
Related Therapeutic Areas
Sponsors
Leads: Fujian Shengdi Pharmaceutical Co., Ltd.