Testing HRS-7535 for heart failure and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.