HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
NCT ID: NCT06391710
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
203 participants
INTERVENTIONAL
2024-05-06
2026-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HRS9531
HRS9531
subcutaneous
Placebo
Placebo
subcutaneous
Interventions
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HRS9531
subcutaneous
Placebo
subcutaneous
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) greater than or equal to 28.0 kg/m\^2
3. New York Heart Association (NYHA) Class II-IV;
4. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
Exclusion Criteria
2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.
18 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HRS9531-205
Identifier Type: -
Identifier Source: org_study_id
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