Clinical Trial

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-01; most recent amendment 2025-12-28.
Status change: Not Yet Recruiting → Recruiting 2025-07-31
Trial Details
NCT Number NCT07060456
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Type 2 Diabetes
Enrollment 300 participants
Start Date 2025-07-25
Primary Completion 2027-02 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-02