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

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.

Study Overview

• Status: Recruiting
• Conditions: Adults With Heart Failure, Mild Decrease in Ejection Fraction/Preserved Ejection Fraction, and Obesity
• Intervention / Treatment: Drug: HRS-7535 tablet; Drug: HRS-7535 tablet placebo

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junmeng Shi; Phone Number: 17721288226; Email: junmeng.shi.js12@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Yuhui Zhang; Phone Number: 010-68314466; Email: yuhuizhangjoy@163.com
      • Principal Investigator: Yuhui Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: HRS-7535 tablet; HRS-7535 tablet.
Placebo Comparator: Treatment group B	Drug: HRS-7535 tablet placebo; HRS-7535 tablet placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage change from baseline in body weight.	At week 36.

Secondary Outcome Measures

Outcome Measure	Time Frame
The concentration of HRS-7535 in plasma.	At week 36.
The percentage change in high-sensitivity C-reactive protein (hsCRP) from baseline.	At week 36.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: HRS-7535-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No