Testing HRS-7535 for heart failure and obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS-7535 in Subjects With Heart Failure, Mild Reduction/Preservation of Ejection Fraction, and Obesity
This study is testing a new medication called HRS-7535 to see if it can help adults with heart failure and obesity feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06820099 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of HRS-7535 in adults suffering from heart failure with preserved ejection fraction and obesity. It is a multicenter, randomized, double-blind, placebo-controlled study that includes a screening period of up to 2 weeks, followed by a 40-week treatment phase and a 1-week safety follow-up. Participants will receive either the HRS-7535 tablet or a placebo to assess the drug's impact on their condition. The study aims to gather data on the drug's effectiveness and safety profile in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic heart failure and a body mass index of 28 kg/m2 or higher.
Not a fit: Patients with heart failure classified as NYHA functional class I or those with significant weight fluctuations prior to the study may not benefit.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and weight management in patients with heart failure and obesity.
How similar studies have performed: Other studies have explored treatments for heart failure with preserved ejection fraction, but the specific approach with HRS-7535 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, on the day of signing the informed consent form, aged between 18 and 80 years old; 2. Diagnosed with chronic heart failure for at least 1 months before screening, and diagnosed with heart failure with preserved ejection fraction according to the National Heart Failure Guidelines 2023 during the screening period; 3. Screening period and day 1 randomization before New York Heart Association (NYHA) functional classification II-IV; 4. During the screening period and on the first day before randomization, the body mass index (BMI) was ≥ 28 kg/m2; 5. Self reported having controlled diet and exercise for 3 months or more before screening, and having a weight change of no more than 5kg within the first 3 months of screening and randomization 6. During the screening period and on the first day of randomization, the total clinical score (KCCQ-CSS) of the Kansas City Cardiomyopathy Questionnaire should be ≤ 80 points; 7. Visit 1 and Visit 2 each undergo a 6MWT, both of which must be ≥ 100 meters and ≤ 425 meters; 8. Prior to screening, the stable dose of medication for underlying diseases (excluding oral diuretics) should be ≥ 4 weeks; 9. Capable and willing to comply with the protocol requirements, fully understand the trial content, process, and possible adverse reactions, capable and willing to comply with the protocol requirements to complete this study (such as subject log recording), able to fully understand and complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire and Patient Health Questionnaire-9 (PHQ-9) scoring. Exclusion Criteria: 1. Individuals with special clinical characteristics or disease history during screening, such as myocardial infarction, acute decompensated heart failure, hospitalization or emergency treatment due to heart failure (excluding hospitalization as specified in the trial protocol), unstable angina, stroke, or transient ischemic attack within the 30 days prior to screening or during the screening period; 2. During the screening period or on the first day of randomization, there may be laboratory tests with clinical significance, such as a 12 lead electrocardiogram indicating persistent sinus tachycardia; 3. Those who have used certain drugs or treatments before screening, such as those that may cause significant weight gain or loss within the past 3 months; 4. Based on the researcher's judgment, there are any situations that may affect the safety of the subjects or interfere with the evaluation of the trial results (such as medical, psychological, social, or geographical factors)
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Junmeng Shi
- Email: Junmeng.shi.js12@hengrui.com
- Phone: 17721288226
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.