Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)

Официальное название

A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of Kylo-11 in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Обзор

This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).

Вмешательства

• Препарат Kylo-11 or matched placebo
  Administered subcutaneously

Первичные конечные точки

• Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 [Срок оценки: Baseline, Weeks 8~26]

Вторичные конечные точки (2)

• Percent change from baseline in time-averaged Lp(a) over Weeks 38~52 [Срок оценки: Baseline, Weeks 38~52]
• Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52 [Срок оценки: Week 26 and Week 52]

Критерии участия

Критерии включения

• Age 18 to 80 years
• Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
• Other inclusion criteria applied per protocol.

Критерии исключения

• Have moderate to severe heart failure (New York Heart Association \[NYHA\] Functional Classification III or IV during Screening) or last known left ventricular ejection fraction <30%
• Have uncontrolled hypertension (systolic blood pressure \[SBP\] ≥160 mmHg or diastolic blood pressure \[DBP\] ≥100 mmHg)
• Have uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
• Have had any malignancy within 5 years prior to randomization (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma that has been successfully treated)
• Other exclusion criteria applied per protocol.

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

Китай · 43 центра

• Peking University First Hospital — Пекин
• The First Affiliated Hospital of Baotou Medical College — Baotou
• Beijing Anzhen Hospital — Пекин
• Beijing Chao-Yang Hospital, Capital Medical University — Пекин
• China-Japan Union Hospital of Jilin University — Changchun
• The First People's Hospital of Changde — Changde
• The Third Xiangya Hospital of Central South University — Чанша
• Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital — Чэнду
• … и ещё 35 центров

США · 16 центров

• Alliance Clinical - Los Angeles — Los Angeles
• Alliance Clinical - San Diego — San Diego
• FOMAT - Comprehensive Cardiovascular Care-Santa Maria California — Santa Maria
• Excel Medical Trials - Flourish Research — Boca Raton
• Clinical Research of West Florida (CRWF) - Clearwater — Clearwater
• Arrow Clinical Trials LLC — Daytona Beach
• Family Research and Healthcare Center Inc. — Doral
• Family Research Centers - Hialeah — Hialeah
• … и ещё 8 центров

Идентификаторы

NCT: NCT07327840 · Kylo-11-II-C01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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