← Trials/Trial dossier/NCT06391710
HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
203
actual
Study population
Heart failure, Obesity / overweight
Key I/E criteria
•BMI ≥28•EF ≥45%
Primary endpoints
•KCCQ clinical summary•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female, age above or equal to 18 years at the time of signing informed consent.
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
1. Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening;
2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
1 endpointHierarchical composite of time to all-cause death
Time frame:From baseline (week 0) to week 36,52
All-cause death
time to event, event
SNOMED 419620001
Weight & body composition
2 endpointsChange in body weight
Time frame:From baseline (week 0) to week 36
Body weight, absolute change (kg)
change from baseline, improvement
Change in body weight
Time frame:From baseline (week 0) to week 52
Body weight, absolute change (kg)
change from baseline, improvement
Heart failure
6 endpointsChange in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Time frame:From baseline (week 0) to week 36
KCCQ clinical summary
change from baseline, improvement
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
Heart-failure composite
event count, event
componentsHeart-failure hospitalization, Urgent heart-failure visit
SNOMED 84114007
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
Heart-failure composite
time to event, event
componentsHeart-failure hospitalization, Urgent heart-failure visit
SNOMED 84114007
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
KCCQ clinical summary
change from baseline, improvement
Change in KCCQ clinical summary score
Time frame:From baseline (week 0) to week 52
KCCQ clinical summary
change from baseline, improvement
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
Time frame:From baseline (week 0) to week 36,52
NT-proBNP, change
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange in C-Reactive Protein (CRP)
Time frame:From baseline (week 0) to week 36,52
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.