Clinical trial NCT06391710: HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
timeFrame: From baseline (week 0) to week 36
measure: Change in body weight
timeFrame: From baseline (week 0) to week 36
Secondary outcomes:
measure: Hierarchical composite of time to all-cause death
timeFrame: From baseline (week 0) to week 36,52
measure: Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
timeFrame: From baseline (week 0) to week 36,52
measure: Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit
timeFrame: From baseline (week 0) to week 36,52
measure: Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks
timeFrame: From baseline (week 0) to week 36,52
measure: Change in KCCQ clinical summary score
timeFrame: From baseline (week 0) to week 52
measure: Change in body weight
timeFrame: From baseline (week 0) to week 52
measure: Change in C-Reactive Protein (CRP)
timeFrame: From baseline (week 0) to week 36,52
measure: Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
timeFrame: From baseline (week 0) to week 36,52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
References: