A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

Официальное название

A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

Обзор

The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).

Подробное описание

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.

Вмешательства

• Препарат SYH2068 Dose 1
  Administered by subcutaneous injection.
• Препарат SYH2068 Dose 2
  Administered by subcutaneous injection.
• Препарат SYH2068 Dose 3
  Administered by subcutaneous injection.
• Препарат Placebo
  Administered by subcutaneous injection.

Первичные конечные точки

• Percentage change in Lp(a) from baseline to Day 60~180 [Срок оценки: Day 60~180]

Вторичные конечные точки (7)

• Percentage change in Lp(a) from baseline to Day 30~540 [Срок оценки: Day 30~540]
• The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L. [Срок оценки: Day 30~540]
• Changes of LDL-C from baseline to Day 30~540 [Срок оценки: Day 30~540]
• Changes of ApoB from baseline to Day 30~540 [Срок оценки: Day 30~540]
• Incidence of TEAEs during the treatment [Срок оценки: During treatment]
• ADA incidence [Срок оценки: During treatment]
• The plasma concentration of SYH2068. [Срок оценки: During treatment]

Критерии участия

Критерии включения

• Male or female participants ≥18 years of age;
• Elevated Lp(a);
• Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;
• Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
• Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.

Критерии исключения

• Diseases that significantly affect Lp(a) during screening period,
• Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
• Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;
• NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
• Type 1 diabetes or hereditary hemorrhagic disorder at screening;
• History of malignant tumor or suspected malignancy within 5 years prior to screening;
• Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
• Allergy to oligonucleotide drugs;
• Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
• Female participants who are pregnant or breastfeeding at screening, or female / male participants who plan to conceive during the study and within 1 year after the last dose.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07640217 · SYH2068-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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