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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS9531 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | subcutaneous |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score | From baseline (week 0) to week 36 | |
| Change in body weight | From baseline (week 0) to week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical composite of time to all-cause death | From baseline (week 0) to week 36,52 | |
| Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit | From baseline (week 0) to week 36,52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
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| Drug |
subcutaneous |
|
| Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit | 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 | From baseline (week 0) to week 36,52 |
| Change in KCCQ clinical summary score | From baseline (week 0) to week 52 |
| Change in body weight | From baseline (week 0) to week 52 |
| Change in C-Reactive Protein (CRP) | From baseline (week 0) to week 36,52 |
| Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP) | From baseline (week 0) to week 36,52 |