Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2

Conditions: Adults With Heart Failure, Mild Decrease in Ejection Fraction/Preserved Ejection Fraction, and Obesity

Treatments: Drug: HRS-7535 tablet placebo; Drug: HRS-7535 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06820099

HRS-7535-206

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase II clinical trial, including a screening period of up to 2 weeks, a 36-weeks' treatment period, and a 1-week safety follow-up visit period.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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225 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: HRS-7535 tablet

Treatment group B

Placebo Comparator group

Treatment:

Drug: HRS-7535 tablet placebo