Survodutide and heart structure and function in people with obesity and fatty liver disease
Tests survodutide against placebo on heart health in adults with overweight and fatty liver.
Plain-language title generated from the registry record
Registry title: ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Key facts
- Where
- Bad Homburg, Erlangen, Freiburg im Breisgau, Leipzig, and Mainz, GermanySee the 5 sites
- Phase
- Phase 3
Where in Germany
- Zentrum für Klinische Studien Bad HomburgBad Homburg, GermanyNo longer taking part
- Universitätsklinikum ErlangenErlangen, GermanyNo longer taking part
- Universitätsklinikum FreiburgFreiburg im Breisgau, GermanyNo longer taking part
- Eugastro GmbHLeipzig, GermanyNo longer taking part
- Universitätsmedizin der Johannes Gutenberg-Universität MainzMainz, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07850063EU 2026-527091-88-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.