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RecruitingNCT06820099Updated Dec 29, 2025

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 Phase 2 interventional study of HRS-7535 tablet and HRS-7535 tablet placebo in Adults With Heart Failure, Mild Decrease in Ejection Fraction/Preserved Ejection Fraction, and Obesity, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 36-weeks' treatment period, and a 1-week safety follow-up visit period.

02

Conditions studied

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

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03

In context

Obesity

6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.

This study's planned enrollment of 225 is above the median of 78 across 4,879 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
225 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Drug: HRS-7535 tablet

  • Placebo comparator
    Treatment group B

    Drug: HRS-7535 tablet placebo

Interventions

  • DrugHRS-7535 tablet

    HRS-7535 tablet.

  • DrugHRS-7535 tablet placebo

    HRS-7535 tablet placebo.

06

What researchers measure

Primary outcomes

  1. The percentage change from baseline in body weight.

    Time frame: At week 36.

Secondary outcomes

  1. The concentration of HRS-7535 in plasma.

    Time frame: At week 36.

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

    Time frame: At week 36.

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06820099
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 11, 2025
Start date
Apr 10, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 29, 2025

Study contacts

Junmeng Shi
Contact
Junmeng.shi.js12@hengrui.com
17721288226

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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