Clinical trial NCT06820099: Efficacy and Safety of HRS-7535 in for Heart Failure With Preserved Ejection Fraction and Obesity
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS-7535 in Subjects With Heart Failure With Preserved Ejection Fraction and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Adults' Obesity With Heart Failure With Preserved Ejection Fraction
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 40-weeks' treatment period, and a 1-week safety follow-up visit period.


Eligibility 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 3 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. Prior to screening, the stable dose of medication for underlying diseases (excluding oral diuretics) should be ≥ 4 weeks;
8. 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).

Primary outcomes:
measure: The percentage change from baseline in body weight.
timeFrame: At week 40.
Secondary outcomes:
measure: The concentration of HRS-7535 in plasma.
timeFrame: At week 40.
measure: The percentage change in high-sensitivity C-reactive protein (hsCRP) from baseline.
timeFrame: At week 40.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: