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

2026年6月1日 更新者：Regeneron Pharmaceuticals

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

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

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

150

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Key Inclusion Criteria:

  1. 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
  2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
  3. 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

Key Exclusion Criteria:

  1. Known chronic liver disease other than Metabolic dysfunction-Associated steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
  2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
  3. History of liver transplantation, current placement on a liver transplant list, or MELD score >12
  4. 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
  5. 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：安慰剂
根据协议进行管理
实验性的：ALN-CIDEB Dose 1
药品：Aln-Cideb
根据协议管理
实验性的：ALN-CIDEB Dose 2
药品：Aln-Cideb
根据协议管理

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
大体时间：At week 26
At week 26

次要结果测量

结果测量
大体时间
Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy
大体时间：At week 52
At week 52
Percent change from baseline in liver fat by MRI-PDFF
大体时间：At week 52
At week 52
Achievement of a ≥30% reduction in liver fat by MRI-PDFF
大体时间：At week 52
At week 52
Achievement of ≤5% liver fat by MRI-PDFF
大体时间：At week 52
At week 52
Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB
大体时间：Up to week 52
Up to week 52
Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH
大体时间：At week 52
At week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to week 64
Up to week 64
Severity of TEAEs
大体时间：Up to week 64
Up to week 64
Change from baseline in FibroScan Controlled Attenuation Parameter (CAP)
大体时间：Through week 52
Through week 52
Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
大体时间：Through week 52
Through week 52
Change from baseline in Aspartate Aminotransferase (AST)
大体时间：Up to week 64
Up to week 64
Change from baseline in Alanine Aminotransferase (ALT)
大体时间：Up to week 64
Up to week 64
Change from baseline in Enhanced Liver Fibrosis (ELF)
大体时间：Through week 52
Through week 52
Change from baseline in PRO-C3
大体时间：Through week 52
Through week 52
Change from baseline in ADAPT
大体时间：Through week 52
Through week 52
Change from baseline in NIS2+
大体时间：Through week 52
Through week 52
Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations
大体时间：At week 52
At week 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2029年2月6日

研究完成 (估计的)

2029年2月6日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ALN-CIDEB-MASH-2603
  • 2026-525916-33-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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