Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Официальное название

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Обзор

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver. The study is looking at: * What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring * How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others

Вмешательства

• Препарат ALN-CIDEB
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol

Первичные конечные точки

• Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) [Срок оценки: At week 26]

Вторичные конечные точки (12)

• Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy [Срок оценки: At week 52]
• Percent change from baseline in liver fat by MRI-PDFF [Срок оценки: At week 52]
• Achievement of a ≥30% reduction in liver fat by MRI-PDFF [Срок оценки: At week 52]
• Achievement of ≤5% liver fat by MRI-PDFF [Срок оценки: At week 52]
• Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB [Срок оценки: Up to week 52]
• Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH [Срок оценки: At week 52]
• Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to week 64]
• Severity of TEAEs [Срок оценки: Up to week 64]
• Change from baseline in FibroScan Controlled Attenuation Parameter (CAP) [Срок оценки: Through week 52]
• Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) [Срок оценки: Through week 52]
• Change from baseline in Aspartate Aminotransferase (AST) [Срок оценки: Up to week 64]
• Change from baseline in Alanine Aminotransferase (ALT) [Срок оценки: Up to week 64]

Критерии участия

Критерии включения

• A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol
• Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
• Has a FibroScan Aspartate aminotransferase (FAST) score >0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol

Критерии исключения

• Known chronic liver disease other than Metabolic dysfunction-Associated steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
• Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
• History of liver transplantation, current placement on a liver transplant list, or MELD score >12
• Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion and/or a score on the AUDIT questionnaire ≥8
• Prior current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria 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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07631637 · ALN-CIDEB-MASH-2603 · 2026-525916-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗