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)
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
34
Recruiting sites
-
Estimated enrollment
600
Study population
Hepatic impairment, Obesity / overweight
Eligibility highlights
•BMI ≥27
Primary endpoint
•Composite average Z-score (dimensionless)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Eligibility criteria
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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
MASH / liver
3 endpointsRelative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
Time frame:At baseline and up to 76 weeks
percent change from baseline, improvement
Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless)
Time frame:At baseline and up to 76 weeks
change from baseline, improvement
Absolute change in hepatic steatosis index (HSI) from baseline to 76 weeks (dimensionless)
Time frame:At baseline and up to 76 weeks
change from baseline, improvement
Heart failure
2 endpointsRelative 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
percent change from baseline, improvement
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
Time frame:At baseline and up to 76 weeks
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointAbsolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
Time frame:At baseline and up to 76 weeks
change from baseline, improvement
Other (unclassified)
3 endpointsComposite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Time frame:At week 76
descriptive
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
descriptive
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
Time frame:At baseline and up to 76 weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.