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ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease

2026年10月29日 更新者：Boehringer Ingelheim

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Phase IIIb Trial to Evaluate the Effect of Survodutide on Cardiac Structure and Function of Participants With Overweight or Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); (ELEVATE-LIVER)

This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD.

Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the participants themselves at home using pre-filled syringes. Participants and doctors do not know who is getting survodutide or placebo.

Participants are in the study for up to 1.5 years. During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff. At some of the visits, doctors use ultrasound scans to check the heart. The results are compared between the 2 groups to see if survodutide helps improve the health of the heart. The study staff also regularly check participants' health and take note of any health problems.

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)

600

阶段

  • 第三阶段

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

学习地点

  • 中国
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
        • 接触：
      • Luoyang、中国、471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • 接触：
      • Nanjing、中国、210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • 接触：
      • Shanghai、中国、200032
        • Zhongshan Hospital Affiliated to Fudan University
        • 接触：
      • Shanghai、中国、200072
        • Shanghai Tenth People's Hospital
        • 接触：
  • 德国
      • Bad Homburg、德国、61348
      • Erlangen、德国、91054
      • Freiburg im Breisgau、德国、79106
      • Leipzig、德国、04103
      • Mainz、德国、55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • 接触：
  • 美国
    • Arizona
      • Peoria、Arizona、美国、85381
        • The Institute for Liver Health II DBA Arizona Clinical Trials
        • 接触：
    • California
      • Los Angeles、California、美国、90048
      • Oxnard、California、美国、93030
      • Pasadena、California、美国、91105
      • West Hills、California、美国、91307
    • Florida
      • University Park、Florida、美国、34201
        • Covenant Metabolic Specialists, LLC - University Park
        • 接触：
    • Kansas
      • Kansas City、Kansas、美国、66160
      • Topeka、Kansas、美国、66606
    • Massachusetts
      • Boston、Massachusetts、美国、02215
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
    • North Carolina
      • Durham、North Carolina、美国、27710
      • Statesville、North Carolina、美国、28625
    • South Carolina
      • Summerville、South Carolina、美国、29485
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
        • 接触：
    • Texas
      • Dallas、Texas、美国、75203
  • 英国
  • 西班牙
      • El Palmar、西班牙、30120
        • Hospital Universitario Virgen de la Arrixaca
        • 接触：
      • Sanlúcar de Barrameda、西班牙、11540
      • Valencia、西班牙、46015

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key inclusion criteria:

  1. Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
  2. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
  3. Body mass index (BMI) ≥27 kg/m²
  4. Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply.

Key exclusion criteria:

  1. Medications for obesity within 3 months before screening
  2. Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products
  3. Established diagnosis of heart failure or a known history of heart failure
  4. Impaired renal function at screening or requiring dialysis Further 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：安慰剂组
组合产品：Placebo matching survodutide

Placebo matching survodutide
实验性的：残余肽臂
组合产品：Survodutide

Survodutide

其他名称：
  • BI456906

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
大体时间：At week 76
At week 76

次要结果测量

结果测量
措施说明
大体时间
Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
大体时间：At baseline and up to 76 weeks

Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated, disease-specific participant-reported outcome measure designed to assess heart failure-related health status. The study will administer the KCCQ 23-item version. All scores range from 0 to 100, with higher scores indicating fewer symptoms and better health status.
At baseline and up to 76 weeks
New use of oral loop diuretics during follow-up from baseline to 76 weeks, irrespective of symptoms (yes/no)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in hepatic steatosis index (HSI) from baseline to 76 weeks (dimensionless)
大体时间：At baseline and up to 76 weeks
At baseline and up to 76 weeks

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

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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11月2日

初级完成 (估计的)

2029年4月29日

研究完成 (估计的)

2029年4月29日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年9月25日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年10月30日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1404-0128
  • 1111-1339-5364 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-527091-88-00 (注册表标识符：CTIS (EU))

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

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 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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