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HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 24, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 203 · Primary completion date: Sep 2025 to Jan 2026 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 200 to confirmed 203
    • Primary completion date: Sep 2025 to Jan 2026
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 2024 to May 6, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to May 6, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase II clinical study to evaluate the efficacy and safety of HRS9531 Injection compared to placebo in obese subjects with heart failure with preserved ejection fraction. A total of 200 obese subjects with heart failure with preserved ejection fraction would be enrolled. Eligible subjects were randomly assigned to either HRS9531 group or placebo group and were treated with HRS9531 injection or placebo, respectively, for 52 weeks.
Trial Details
NCT Number NCT06391710
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Heart Failure With Preserved Ejection Fraction
Enrollment 203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov