Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)

Обзор

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Подробное описание

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Вмешательства

• Препарат Pelacarsen
  Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
• Препарат Placebo
  Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
• Препарат Inclisiran
  All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.

Первичные конечные точки

• Change in log transformed lipoprotein A (Lp(a)) concentration [Срок оценки: Baseline, 6 Months]

Вторичные конечные точки (4)

• Proportion of participants achieving reduction in Lp(a) levels at Month 6 [Срок оценки: Baseline, Month 6]
• Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) [Срок оценки: 16 Months]
• Incidence of treatment emergent adverse events of special interest (AESI) [Срок оценки: 12 Months]
• Incidence of study and treatment discontinuations due to TEAEs [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• Male and female participants 18 to ≤80 years of age at Screening visit
• Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
• On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
• Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
• On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
• Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
• Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Критерии исключения

• Prior treatment with inclisiran
• Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
• Uncontrolled hypertension at Randomization/Baseline visit
• Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
• Triglycerides ≥400 mg/dL at Screening visit
• History of malignancy of any organ system within the past 5 years
• Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
• Central laboratory reported platelet count <140,000 per mm3
• Active liver disease or hepatic dysfunction at Screening visit
• Significant kidney disease at Screening visit
• Pregnant or nursing women at Screening visit
• Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

• Other protocol-defined inclusion/exclusion criteria may apply.

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

США · 36 центров

• Parkway Medical Center — Birmingham
• Clinical Research Inst of Arizona — Sun City West
• National Heart Institute — Beverly Hills
• Interv Cardiology Med Grp — West Hills
• Excel Medical Clinical Trials LLC — Boca Raton
• Jacksonville Center for Clinical — Jacksonville
• K2 Medical Research LLC — Maitland
• University of Miami Hospital — Miami
• … и ещё 28 центров

Испания · 11 центров

• Novartis Investigative Site — Santiago Compostela
• Novartis Investigative Site — Pamplona
• Novartis Investigative Site — Castilleja de la Cuesta
• Novartis Investigative Site — A Coruña
• Novartis Investigative Site — Barcelona
• Novartis Investigative Site — Córdoba
• … и ещё 5 центров

Германия · 10 центров

• Novartis Investigative Site — Stuttgart
• Novartis Investigative Site — Potsdam
• Novartis Investigative Site — Chemnitz
• Novartis Investigative Site — Leipzig
• Novartis Investigative Site — Berlin
• Novartis Investigative Site — Bielefeld
• Novartis Investigative Site — Gelnhausen
• Novartis Investigative Site — Mannheim
• … и ещё 2 центра

Франция · 9 центров

• Novartis Investigative Site — Béziers
• Novartis Investigative Site — Cholet
• Novartis Investigative Site — Grenoble
• Novartis Investigative Site — Lille
• Novartis Investigative Site — Montpellier
• Novartis Investigative Site — Paris
• Novartis Investigative Site — Pessac
• Novartis Investigative Site — Poitiers
• … и ещё 1 центр

Италия · 9 центров

• Novartis Investigative Site — Ancona
• Novartis Investigative Site — Caserta
• Novartis Investigative Site — Grosseto
• Novartis Investigative Site — Milan
• Novartis Investigative Site — Rozzano
• Novartis Investigative Site — Perugia
• Novartis Investigative Site — Pordenone
• Novartis Investigative Site — Salerno
• … и ещё 1 центр

Китай · 5 центров

• Novartis Investigative Site — Иньчуань
• Novartis Investigative Site — Jining
• Novartis Investigative Site — Сиань
• Novartis Investigative Site — Пекин
• Novartis Investigative Site — Шанхай

Тайвань · 5 центров

Список центров уточняется — проверьте первичный протокол.

Великобритания · 5 центров

Список центров уточняется — проверьте первичный протокол.

Гонконг · 2 центра

• Novartis Investigative Site — Гонконг
• Novartis Investigative Site — Гонконг

Нидерланды · 2 центра

• Novartis Investigative Site — The Hague
• Novartis Investigative Site — Enschede

Пуэрто-Рико · 1 центр

• Latin Clinical Trial Center Inc — San Juan

Идентификаторы

NCT: NCT06813911 · CTQJ230A12304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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