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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
203
subcutaneous
subcutaneous
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Time frame: From baseline (week 0) to week 36
Change in body weight
Time frame: From baseline (week 0) to week 36
Hierarchical composite of time to all-cause death
Time frame: From baseline (week 0) to week 36,52
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
Time frame: From baseline (week 0) to week 36,52
Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit
Time frame: From baseline (week 0) to week 36,52
Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks
Time frame: From baseline (week 0) to week 36,52
Change in KCCQ clinical summary score
Time frame: From baseline (week 0) to week 52
Change in body weight
Time frame: From baseline (week 0) to week 52
Change in C-Reactive Protein (CRP)
Time frame: From baseline (week 0) to week 36,52
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
Time frame: From baseline (week 0) to week 36,52
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