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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Interventions: HRS953 (Drug), HRS953 (Drug), Placebo (Drug) to HRS9531 (Drug), HRS9531 (Drug), Placebo (Drug)v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Jul 25, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Jul 25, 2025
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07060456
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Type 2 Diabetes
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov