RecruitingPhase 2NCT06820099

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


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

225 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether HRS-7535, an investigational weight-loss drug in the GLP-1/GIP receptor agonist class, can improve heart function and reduce symptoms in people who have heart failure with a preserved or mildly reduced pumping ability, and who are also obese. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with chronic heart failure for at least 1 month - Your heart failure is the type with preserved or mildly reduced ejection fraction - Your BMI is 28 or above - You have had stable diet and exercise habits for the past 3 months with no major weight changes - Your heart failure symptoms are classified as NYHA Class II-IV **You may NOT be eligible if...** - You have type 1 diabetes or require insulin treatment - You have serious kidney, liver, or pancreatic disease - You are pregnant or breastfeeding - You have had a recent heart attack or hospitalization for heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-7535 tablet

HRS-7535 tablet.

DRUGHRS-7535 tablet placebo

HRS-7535 tablet placebo.


Locations(1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06820099