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A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) (ALLSTAR)

2026年9月15日 更新者：GlaxoSmithKline

A Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment With Efimosfermin Alfa in Adult Participants With Alcohol-related Liver Disease (ALD)

This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

274

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

研究联系人备份

学习地点

  • 美国
    • Kansas
      • Topeka、Kansas、美国、66606
        • 招聘中
        • GSK Investigational Site
        • 首席研究员：
          • Shekhar Challa
        • 接触：
        • 接触：
    • Texas
      • Fort Worth、Texas、美国、76104
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Thomas Cotter
      • San Antonio、Texas、美国、78215
        • 招聘中
        • GSK Investigational Site
        • 首席研究员：
          • Eric Lawitz
        • 接触：
        • 接触：

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

Inclusion Criteria:

  • Participant must be 18 to 75 years of age inclusive, at the time of Screening.
  • Capable of giving signed informed consent prior to the performance of any study-specific procedures.
  • Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
  • History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.

  • A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:

    • Is a Participant of non-childbearing potential (PONCBP) OR
    • Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), 30 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention.

Exclusion Criteria:

  • Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.
  • Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab

  • History of diabetes mellitus (DM), either:

    • Type 1 DM
    • Type 2 DM with unstable glycemic control or with major complications.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.
  • Current, or history of known hepatocellular carcinoma (HCC).
  • Any major surgery within 3 months prior to Screening 1 or planned during the study
  • Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator.
  • All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period.
  • Poorly controlled hypertension.
  • Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia.
  • Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1.
  • Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded.
  • Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD.
  • Current or planned participation in any clinical trial of investigational therapies or medical devices.
  • Exceeding pre-defined laboratory parameters for Triglycerides, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), International normalised ratio (INR), Albumin, Urine albumin-creatinine ratio (uACR) or Glycosylated Hemoglobin (HbA1c).
  • History of drug abuse within the 12 months prior to Day 1 or evidence of such abuse as indicated by laboratory assays conducted at Screening.
  • History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and/or its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics.
  • Overt hepatic encephalopathy (West Haven grade >=2).

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：不适用
  • 介入模型：顺序分配
  • 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
参与者将接受安慰剂。
药品：安慰剂
将给予安慰剂。
实验性的：Efimosfermin alfa Dose Level 1
Participants will receive efimosfermin alfa dose level 1.
药品：Efimosfermin alfa
Efimosfermin alfa will be administered.
实验性的：Efimosfermin alfa Dose Level 2
Participants will receive efimosfermin alfa dose level 2.
药品：Efimosfermin alfa
Efimosfermin alfa will be administered.
实验性的：Efimosfermin alfa Dose Level 3
Participants will receive efimosfermin alfa dose level 3.
药品：Efimosfermin alfa
Efimosfermin alfa will be administered.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
大体时间：Baseline (Day 1) and up to Week 60
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)
Baseline (Day 1) and up to Week 60
Change from Baseline in model for end-stage liver disease (MELD) score
大体时间：Baseline (Day 1) and up to Week 60
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Baseline (Day 1) and up to Week 60

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
大体时间：Baseline (Day 1) and up to Week 60
This is a measurement of the AST enzyme in the blood.
Baseline (Day 1) and up to Week 60
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
大体时间：Baseline (Day 1) and up to Week 52
Baseline (Day 1) and up to Week 52
Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa
大体时间：Up to Week 56
Up to Week 56
Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling
大体时间：Up to Week 4
Up to Week 4
Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling
大体时间：Up to Week 4
Up to Week 4
Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
大体时间：Up to Week 56
Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
大体时间：Up to Week 60
Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
大体时间：Up to Week 60
Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
大体时间：Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in Vital signs
大体时间：Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
大体时间：Up to Week 60
Up to Week 60

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

GlaxoSmithKline

调查人员

  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

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 (实际的)

2026年8月31日

初级完成 (估计的)

2028年8月11日

研究完成 (估计的)

2030年1月14日

研究注册日期

首次提交

2026年8月21日

首先提交符合 QC 标准的

2026年8月21日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9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

  • 306837
  • 2026-526391-23 (其他标识符：EU CT Number)

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

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD 共享时间框架

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD 共享访问标准

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 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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