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RecruitingPhase 2

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

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

225

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoint

Body weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06820099
Org study IDHRS-7535-206

Timeline

Milestones

Study first posted2025-02-11actual
Study start2025-04-10actual
Last update posted2025-12-29actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Cardiometabolic biomarkers
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

The percentage change from baseline in body weight.

Time frame:At week 36.

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

The percentage change in high-sensitivity C-reactive protein (hsCRP) from baseline.

Time frame:At week 36.

percent change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

The concentration of HRS-7535 in plasma.

Time frame:At week 36.

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.