ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular, liver
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥27 required; conditions: Obesity; Metabolic Dysfunction-associated Steatotic Liver Disease
- Interventions
- Survodutide; Placebo matching survodutide
- Conditions
- Obesity; Metabolic Dysfunction-associated Steatotic Liver Disease
- Phase and size
- Phase 3 · 600 participants
- Dates
- Start 2026-10-23
Primary completion 2029-04-29 - Sponsor
- Boehringer Ingelheim (Industry)
- Last checked
- Oct 18, 2026
01Endpoints
What the trial will measure
- Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parametersAt week 76
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.