HRS9531 injection for obese patients with heart failure
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
PHASE2 · Fujian Shengdi Pharmaceutical Co., Ltd. · NCT06391710
This study is testing if an injection called HRS9531 can help obese people with heart failure feel better over a year compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. (industry) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06391710 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of HRS9531 injection in obese individuals suffering from heart failure with preserved ejection fraction. It is a multicenter, randomized, double-blind, placebo-controlled Phase II study involving 200 participants who will be treated for 52 weeks. Participants will be randomly assigned to receive either the HRS9531 injection or a placebo, allowing for a direct comparison of outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are obese adults aged 18 and older with heart failure classified as NYHA Class II-IV and a left ventricular ejection fraction of 45% or higher.
Not a fit: Patients with a history of recent myocardial infarction, unstable angina, or poorly controlled diabetes (HbA1c ≥ 11.0%) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and overall health in obese patients with heart failure.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating heart failure, making this a potentially valuable investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Zhou Li
- Email: zhou.li.zl69@hengrui.com
- Phone: +86 17721288193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Preserved Ejection Fraction