Clinical trial
HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT06391710
Active, not recruitingPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHeart Failure With Preserved Ejection Fraction
Full registry 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.
Treatments and study arms
HRS9531
Drug
subcutaneous
Placebo
Drug
subcutaneous
Primary outcomes
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary scoreFrom baseline (week 0) to week 36
Change in body weightFrom baseline (week 0) to week 36
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Beijing Anzhen Hospital, Capital Medical University🇨🇳 Beijing, Beijing Municipality, China