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

October 29, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm
Combination product: Placebo matching survodutide

Placebo matching survodutide
Experimental: Survodutide arm
Combination product: Survodutide

Survodutide

Other Names:
  • BI456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Time Frame: At week 76
At week 76

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
Time Frame: 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 (%)
Time Frame: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: At baseline and up to 76 weeks
At baseline and up to 76 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

April 29, 2029

Study Completion (Estimated)

April 29, 2029

Study Registration Dates

First Submitted

September 25, 2026

First Submitted That Met QC Criteria

September 25, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

October 30, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-0128
  • 1111-1339-5364 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-527091-88-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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