ObesityPhase 3NCT07850063
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 Phase 3 study testing Survodutide in people with Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease, run by Boehringer Ingelheim at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- Survodutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 23 Oct 2026to 29 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply.
Who cannot join
- 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
- Impaired renal function at screening or requiring dialysis Further exclusion criteria apply.
Trial locations and contacts
25 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 5 countries
United States13 sites
Southwest Gastroenterology Associates, P.C.
Albuquerque, New Mexico, 87109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Methodist Dallas Medical Center
Dallas, Texas, 75203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Duke University Medical Center
Durham, North Carolina, 27710
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of Kansas Medical Center
Kansas City, Kansas, 66160
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Fomat Medical Research
Oxnard, California, 93030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
California Liver Research Institute
Pasadena, California, 91105
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, 85381
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Palmetto Clinical Research
Summerville, South Carolina, 29485
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Kansas Medical Clinic PA
Topeka, Kansas, 66606
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, 34201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
United Kingdom6 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
St James's University Hospital
Leeds, LS9 7TF
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Leicester Royal Infirmary
Leicester, LE1 5WW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
St Bartholomew's Hospital
London, EC1A 7BE
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Guy's Hospital
London, SE1 9RT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Derriford Hospital
Plymouth, PL6 8DH
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Germany3 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Eugastro GmbH
Leipzig, 04103
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
China2 sites
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Spain1 site
Ascires
Valencia, 46015
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
About this study
Official title: 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.
- Being tested
- Survodutide, Placebo matching survodutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvodutideCombination product
Also called BI456906
Survodutide
Placebo matching survodutideCombination product
Placebo matching survodutide
| Study group | Role | What they receive |
|---|---|---|
| Survodutide arm | Experimental | Not described Receives: Combination Product: Survodutide |
| Placebo arm | Placebo comparator | Not described Receives: Combination Product: Placebo matching survodutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Measured: At week 76
Secondary outcomes (8)
Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
Measured: At baseline and up to 76 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
Measured: At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
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.
Measured: 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)
Measured: At baseline and up to 76 weeks
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
Measured: At baseline and up to 76 weeks
Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless)
Measured: At baseline and up to 76 weeks
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
Measured: At baseline and up to 76 weeks
Absolute change in hepatic steatosis index (HSI) from baseline to 76 weeks (dimensionless)
Measured: At baseline and up to 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start23 Oct 2026 (estimated)
- Primary completion29 Apr 2029 (estimated)
- Study completion29 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850063
- Sponsor's protocol ID
- 1404-0128
- Other IDs
- 1111-1339-5364, 2026-527091-88-00
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07850063
- Acronym / sponsor ID
- 1404-0128
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 29 Apr 2029 (estimated)
- Study completion
- 29 Apr 2029 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survodutide arm | Experimental | Combination Product: Survodutide |
| Placebo arm | Placebo comparator | Combination Product: Placebo matching survodutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply.
Key exclusion criteria (4 listed)
- 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
- Impaired renal function at screening or requiring dialysis Further exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvodutideAlso: BI456906Survodutide | Combination product | Survodutide arm |
| Placebo matching survodutidePlacebo matching survodutide | Combination product | Placebo arm |
Primary outcome
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Time frame: At week 76
8 secondary outcomes
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
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
Time frame: 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
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
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
Time frame: 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
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Survodutide in people with Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease, run by Boehringer Ingelheim at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, Germany, China, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (18002430127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters (time frame: At week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.