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Tests treatment safety and results for Adults With Heart Failure, Mild Decrease in Ejection...
Official title Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity
ClinicalTrials.gov ID: NCT06820099
What this study is testing
What is HRS-7535 tablet?
HRS-7535 tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adults with heart failure, mild decrease in ejection fraction/preserved ejection fraction, and obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female, on the day of signing the informed consent form, aged between 18 and 80 years old;
- Diagnosed with chronic heart failure for at least 1 months before screening, and diagnosed with heart failure with preserved ejection fraction...
- Screening period and day 1 randomization before New York Heart Association (NYHA) functional classification II-IV;
- During the screening period and on the first day before randomization, the body mass index (BMI) was ≥ 28 kg/m2;
- 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...
You likely can't join if
- Individuals with special clinical characteristics or disease history during screening, such as myocardial infarction, acute decompensated heart...
- During the screening period or on the first day of randomization, there may be laboratory tests with clinical significance, such as a 12 lead...
- 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...
- Based on the researcher's judgment, there are any situations that may affect the safety of the people or interfere with the evaluation of the trial...
See the full eligibility criteria
- Male or female, on the day of signing the informed consent form, aged between 18 and 80 years old;
- 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...
- Screening period and day 1 randomization before New York Heart Association (NYHA) functional classification II-IV;
- During the screening period and on the first day before randomization, the body mass index (BMI) was ≥ 28 kg/m2;
- 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
- 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;
- Visit 1 and Visit 2 each undergo a 6MWT, both of which must be ≥ 100 meters and ≤ 425 meters;
- Prior to screening, the stable dose of medication for underlying diseases (excluding oral diuretics) should be ≥ 4 weeks;
- 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...
- 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...
- 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;
- 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;
- Based on the researcher's judgment, there are any situations that may affect the safety of the people or interfere with the evaluation of the trial results (such as medical, psychological, social, or geographical...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.