Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-25; most recent amendment 2025-11-20.
Status change: Recruiting → Active, Not Recruiting 2025-11-20
Status change: Not Yet Recruiting → Recruiting 2024-05-16
Trial Details
NCT Number NCT06391710
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Heart Failure With Preserved Ejection Fraction
Enrollment 203 participants
Start Date 2024-05-06
Primary Completion 2026-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-24