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

What Was Tested

In this phase 3 trial, researchers set out to test Survodutide for fatty liver & elevated liver enzymes.

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.

It had two arms (groups): Survodutide arm (experimental) and Placebo arm (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 600 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

The Survodutide group and the comparison group ran side by side rather than switching.

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Survodutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-10-23 with completion listed for 2029-04-29.

It ran at 25 sites in United States (13), United Kingdom (6), Germany (3), China (2) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters (time frame: At week 76).

It also tracked 8 secondary outcomes, for example Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%), Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%), Absolute change in KCCQ from baseline to 76 weeks (dimensionless), New use of oral loop diuretics during follow-up from baseline to 76 weeks, irrespective of symptoms (yes/no), Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg) and Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 600 people with fatty liver & elevated liver enzymes.

With 600 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, Fatty liver & elevated liver enzymes research.