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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат HRS-7535 tablet
  HRS-7535 tablet.
• Препарат HRS-7535 tablet placebo
  HRS-7535 tablet placebo.

Первичные конечные точки

• The percentage change from baseline in body weight. [Срок оценки: At week 36.]

Вторичные конечные точки (2)

• The concentration of HRS-7535 in plasma. [Срок оценки: At week 36.]
• The percentage change in high-sensitivity C-reactive protein (hsCRP) from baseline. [Срок оценки: At week 36.]

Критерии участия

Критерии включения

• 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 period;
• 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 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.

Критерии исключения

• 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;
• 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 subjects or interfere with the evaluation of the trial results (such as medical, psychological, social, or geographical factors)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06820099 · HRS-7535-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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