Study to Evaluate ALN-CIDEB in Adults With Fibrotic Alcohol-Associated Liver Disease (ALD)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALN-CIDEB in Adults With Alcohol-Associated Liver Disease (ALD) With Moderate to Advanced Fibrosis
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called alcohol-associated liver disease (ALD). ALD is a type of liver disease caused by drinking alcohol at levels that are harmful to the body. The study will also test ALN-CIDEB in participants who are known to have metabolic dysfunction- and alcohol- associated liver disease (MetALD), a subgroup of people that have features of both ALD and metabolic dysfunction-associated steatotic liver disease (MASLD).
The study will compare 2 different dose regimens of ALN-CIDEB with placebo (something that looks like the study drug but doesn't contain any medicine) 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 and stiffness of the liver
- How ALN-CIDEB could affect the liver proteins
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Trials Administrator
- 电话号码：844-734-6643
- 邮箱：clinicaltrials@regeneron.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Has a diagnosis of alcohol-associated liver disease (with or without MetALD), as determined by the investigator
- Has a liver stiffness measurement ≥7 and <20 kilopascal (kPa) by FibroScan at Screening Visit 1
- Has a controlled attenuation parameter ≥285 decibels per meter (dB/m) by FibroScan at Screening Visit 1
- Has liver fat content ≥8.5% by MRI-PDFF at Screening Visit 2
Key Exclusion Criteria:
- Has known chronic liver disease other than MetALD or ALD, as determined by the investigator and as defined in the protocol
- Has history of or current alcohol-associated hepatitis (AH) at screening, as determined by the investigator
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
学习计划
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
|
Administered per the protocol |
|
实验性的：ALN-CIDEB Dose Level 1
|
Administered per the protocol |
|
实验性的：ALN-CIDEB Dose Level 2
|
Administered per the protocol |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
大体时间：Through Week 64
|
Through Week 64
|
|
Severity of TEAEs
大体时间：Through Week 64
|
Through Week 64
|
|
Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat fraction (MRI-PDFF)
大体时间：At Week 52
|
At Week 52
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from Baseline in Aspartate Aminotransferase (AST)
大体时间：Through Week 64
|
Through Week 64
|
|
Change from Baseline in Alanine Aminotransferase (ALT)
大体时间：Through Week 64
|
Through Week 64
|
|
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 Enhanced Liver Fibrosis (ELF)
大体时间：Through Week 52
|
Through Week 52
|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
大体时间：Through Week 52
|
Through Week 52
|
合作者和调查者
调查人员
- 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- 慢性肝病
- 肝脂肪变性
- 肝硬化
- siRNA
- 肝纤维化
- 酒精性肝炎
- 晚期纤维化
- 门静脉高压症
- 酒精使用障碍（澳元）
- 肝纤维化
- 酒精性肝病
- 脂肪肝病
- 小干扰核糖核酸
- 代谢功能障碍相关脂肪性肝炎 (MASH)
- 终末期肝病
- Alcohol-Related Liver Disease
- Alcoholic Cirrhosis
- Alcohol-Induced Liver Disease
- Alcohol-Associated Hepatitis (AH)
- Alcohol-Associated Steatohepatitis (ASH)
- Alcoholic Steatohepatitis
- Alcohol-Associated Steatosis
- Alcoholic Fatty Liver
- Alcohol-Associated Cirrhosis
- Moderate Fibrosis
- Acute-on-Chronic Liver Failure (ACLF)
- Liver Disease from Alcohol
- Alcohol-Related Liver Damage
- Metabolic dysfunction- and alcohol- associated liver disease (MetALD)
其他相关的 MeSH 术语
其他研究编号
- ALN-CIDEB-ALD-25113
- 2026-527097-37-00 (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)？
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
研究美国 FDA 监管的设备产品
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.