ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
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)
3 other identifiers
interventional
600
5 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Oct 2026
Typical duration for phase_3 obesity
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
September 30, 2026
CompletedStudy Start
First participant enrolled
October 23, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2029
Study Completion
Last participant's last visit for all outcomes
April 29, 2029
September 30, 2026
September 1, 2026
2.5 years
September 25, 2026
September 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
At week 76
Secondary Outcomes (8)
Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
At baseline and up to 76 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
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)
At baseline and up to 76 weeks
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
At baseline and up to 76 weeks
- +3 more secondary outcomes
Study Arms (2)
Survodutide arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
- Body mass index (BMI) ≥27 kg/m²
You may not qualify if:
- Medications for obesity within 3 months before screening
- Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products
- Established diagnosis of heart failure or a known history of heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, 85381, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Fomat Medical Research
Oxnard, California, 93030, United States
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, 34201, United States
Kansas Medical Clinic PA
Topeka, Kansas, 66606, United States
Southwest Gastroenterology Associates, P.C.
Albuquerque, New Mexico, 87109, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032, China
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Ascires
Valencia, 46015, Spain
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2026
First Posted
September 30, 2026
Study Start (Estimated)
October 23, 2026
Primary Completion (Estimated)
April 29, 2029
Study Completion (Estimated)
April 29, 2029
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.