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Идёт набор NCT07349615

A Study of SHR-1918 In Participants With Hypertriglyceridemia

Фаза III С лечением Hypertriglyceridemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SHR-1918/ SHR-1918 placebo, SHR-1918/ SHR-1918 placebo.
Кому может быть актуально
Состояния в реестре: Hypertriglyceridemia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia

Обзор

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

Вмешательства

  • Препарат SHR-1918/ SHR-1918 placebo
    SHR-1918/ SHR-1918 placebo Dose 1
  • Препарат SHR-1918/ SHR-1918 placebo
    SHR-1918/ SHR-1918 placebo Dose 2

Первичные конечные точки

  • Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline [Срок оценки: at 20 weeks and 24 weeks of treatment]
Вторичные конечные точки (12)
  • Percentage change in non-HDL-C relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Percentage change in LDL-C relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Percentage change in TC relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Percentage change in ApoB relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Percentage change in ApoA1 relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in TG relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in non-HDL-C relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in LDL-C relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in TC relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in ApoB relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change in ApoA1 relative to baseline [Срок оценки: at 24 weeks of treatment]
  • Change and percentage change in Lp(a) relative to baseline [Срок оценки: at 24 weeks of treatment]

Критерии участия

Критерии включения

  • Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
  • 1.7 ≤ TG ≤ 5.6 mmol/L.
  • LDL-C < 3.4 mmol/L.
  • Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.

Критерии исключения

  • History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
  • Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
  • Have a history of pancreatitis prior to screening or randomization.
  • Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  • Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
  • Malignant tumors within 5 years.
  • Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
  • Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
  • Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  • Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.

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
  • Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT07349615 · SHR-1918-305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗