A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Обзор

The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.

Вмешательства

• Препарат SHR-1918
  SHR-1918
• Препарат SHR-1918 placebo
  SHR-1918 placebo

Первичные конечные точки

• The percentage change of serum LDL-C from baseline; [Срок оценки: Baseline and Week 24]
• The percentage change in serum TG from baseline; [Срок оценки: Baseline and Week 24]

Вторичные конечные точки (12)

• Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline; [Срок оценки: Baseline and Week 24]
• The percentage change in serum total cholesterol (TC) from baseline; [Срок оценки: Baseline and Week 24]
• The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24; [Срок оценки: Baseline and Week 24]
• The percentage change of serum apolipoprotein A1 (ApoA1) from baseline; [Срок оценки: Baseline and Week 24]
• The change from baseline in serum LDL-C； [Срок оценки: Baseline and Week 24]
• The change from baseline in serum TG； [Срок оценки: Baseline and Week 24]
• The change from baseline in serum non-HDL-C； [Срок оценки: Baseline and Week 24]
• The change from baseline in serum TC； [Срок оценки: Baseline and Week 24]
• The change from baseline in serum ApoB； [Срок оценки: Baseline and Week 24]
• The change from baseline in serum ApoA1； [Срок оценки: Baseline and Week 24]
• Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a)); [Срок оценки: Baseline and Week 24]
• Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C); [Срок оценки: Baseline and Week 24]

Критерии участия

Критерии включения

• the age must be at least 18 years old, and both men and women are eligible;
• the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
• Fasting TG≥ 1.7 mmol/L;
• Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person；

Критерии исключения

• poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) > 3× upper limit of normal (ULN), or total bilirubin > 2×ULN；
• Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
• The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2；
• Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc

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

• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07230730 · SHR-1918-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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