A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)

Обзор

The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.

Вмешательства

• Препарат HRS9531
  HRS9531 Dose 1 , subcutaneous injection
• Препарат HRS9531 placebo
  HRS9531 placebo Dose 1, subcutaneous injection

Первичные конечные точки

• The time from randomization to the first occurrence of the MACE-3 composite endpoint [Срок оценки: approximately up to 61 months of treatment]

Вторичные конечные точки (12)

• Time to the first occurrence of the MACE-4 composite endpoint [Срок оценки: approximately up to 61 months of treatment]
• Time to the first occurrence of the extended MACE composite endpoint [Срок оценки: approximately up to 61 months of treatment]
• Time to the first occurrence of the composite endpoint of heart failure； [Срок оценки: approximately up to 61 months of treatment]
• Time to the first occurrence of the composite endpoint of kidney disease； [Срок оценки: approximately up to 61 months of treatment]
• Time to the first occurrence of the composite endpoint of major adverse limb events； [Срок оценки: approximately up to 61 months of treatment；]
• Time when each component event of the MACE-3 composite endpoint occurred for the first time [Срок оценки: approximately up to 61 months of treatment；]
• Time when all-cause death occurs； [Срок оценки: approximately up to 61 months of treatment；]
• Time to the first hospitalization due to heart failure； [Срок оценки: approximately up to 61 months of treatment；]
• Time to the first emergency heart failure visit； [Срок оценки: approximately up to 61 months of treatment；]
• Time when the first persistent eGFR decreased by ≥50% from baseline； [Срок оценки: approximately up to 61 months of treatment；]
• Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time； [Срок оценки: approximately up to 61 months of treatment；]
• Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ； [Срок оценки: approximately up to 61 months of treatment；]

Критерии участия

Критерии включения

• Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months
• The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ²

Критерии исключения

• Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening
• Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
• When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, and intermittent claudication
• Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
• Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases
• Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ
• Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures
• Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery
• Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes
• Acute complications of diabetes occurred within one month before screening
• There are endocrine diseases that may significantly affect weight

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, CAMS&PUMC — Пекин

Идентификаторы

NCT: NCT07551492 · HRS9531-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗