A Phase 3 clinical trial (NCT06649344) evaluating HRS9531 versus semaglutide once weekly as an add-on therapy for participants with Type 2 Diabetes reached its primary completion on 2026-07-18. This milestone indicates that data collection for the primary outcome measures has concluded for the study comparing the two treatments.
Background
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, widely used in the management of Type 2 Diabetes. This trial investigates HRS9531 as a potential new treatment option, with semaglutide serving as the active comparator.
Trial design
The study, identified as NCT06649344, is a Phase 3 trial. It enrolled 884 participants with Type 2 Diabetes whose condition was not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors. The trial's objective is to evaluate the efficacy and safety of HRS9531 once weekly compared to semaglutide once weekly over 36 and 52 weeks. Interventions included HRS9531 injection and semaglutide injection.
What this means
The primary completion of this Phase 3 trial signifies that all necessary data for the study's primary endpoint have been collected. Researchers will now proceed with data analysis to determine the efficacy and safety profile of HRS9531 relative to semaglutide in the specified patient population. The results are anticipated to provide crucial insights into the potential role of HRS9531 in the treatment landscape for Type 2 Diabetes.
Source
This information is based on the primary completion status of trial NCT06649344, updated on 2026-07-18. Full details are available on clinicaltrials.gov.