A Phase 3 clinical trial comparing HRS-7535 with dapagliflozin in adult participants with Type 2 Diabetes completed its primary study on 2026-05-29. The trial, identified as NCT06589765, enrolled 810 participants to evaluate the efficacy and safety of HRS-7535 against dapagliflozin in subjects with inadequate glycemic control using metformin.
Background
Dapagliflozin is an established medication used in the management of Type 2 Diabetes Mellitus. It is an SGLT2 inhibitor often prescribed for patients whose glycemic control is inadequate with metformin alone. The current trial investigates HRS-7535 as a potential new treatment option, comparing its performance directly against dapagliflozin to assess its efficacy and safety profile.
Trial design
The study, designated NCT06589765, is a Phase 3 trial with an enrollment of 810 adult participants. It focuses on individuals diagnosed with Type 2 Diabetes Mellitus who have inadequate glycemic control despite treatment with metformin. The trial aims to compare the efficacy and safety of an investigational drug, HRS-7535 tablet, against the established medication, dapagliflozin tablet.
What this means
The primary completion of this Phase 3 study signifies that the core data collection period for the main efficacy and safety endpoints has concluded. Researchers will now proceed with data analysis to determine how HRS-7535 compares to dapagliflozin in adult participants with Type 2 Diabetes. The results of this comparison will be crucial for understanding the potential role of HRS-7535 in the treatment landscape for this condition, particularly for patients whose diabetes is not adequately controlled by metformin.
Source
This information is based on the primary completion status reported on ClinicalTrials.gov for study NCT06589765, with an event date of 2026-05-29. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).