Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy

Обзор

To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.

Вмешательства

• Препарат QLC7401
  QLC7401 combined with lipid-lowering agents
• Препарат Placebo
  Placebo combined with lipid-lowering agents

Первичные конечные точки

• Percentage changes in LDL-C from baseline to Day 180 and Day 270 [Срок оценки: 80 days and 270 days]

Вторичные конечные точки (11)

• Percentage changes in LDL-C from baseline at each subsequent visit to Day 360 [Срок оценки: 360 days]
• Value changes in LDL-C from baseline at each subsequent visit to Day 360 [Срок оценки: 360 days]
• Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360 [Срок оценки: 360 days]
• Value changes in PCSK9 from baseline at each subsequent visit to Day 360 [Срок оценки: 360 days]
• Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360 [Срок оценки: 360 days]
• Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360 [Срок оценки: 360 days]
• Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360 [Срок оценки: 360 days]
• Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein [Срок оценки: 360 days]
• Proportion of participants who attained global lipid modification targets for level of ASCVD risk [Срок оценки: 360 days]
• Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments [Срок оценки: 360 days]
• ADA incidence [Срок оценки: 360 days]

Критерии участия

Критерии включения

• Male or female participants aged ≥18 years of age.
• Serum LDL-C ≥1.8mmol/L for ASCVD participants or ≥2.6mmol/L for other participants at screening.
• Fasting TG <400mg/dL (<4.5mmol/L) at screening.
• Stable lipid-lowering therapy for ≥4 weeks at randomization.
• Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Критерии исключения

• Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade II-IV at screening or randomization or latest detected LVEF<30%; (2) CVD events within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years.
• Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN.
• General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating.
• The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06750341 · QLC7401-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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