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A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

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Trial Profile

A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2024

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At a glance

  • Drugs HRS 9531 (Primary) ; Semaglutide
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors Fujian Shengdi Pharmaceutical
  • Most Recent Events

    • 02 Dec 2024 Protocol amended to change time frame from week 32 to week 36 and 52.
    • 02 Dec 2024 Planned End Date changed from 31 Mar 2026 to 30 Sep 2026.
    • 02 Dec 2024 Planned primary completion date changed from 31 Mar 2026 to 30 Sep 2026.

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