Phase 3Not yet recruiting
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)
- Sponsor
- Boehringer Ingelheim (Industry)
- Enrollment
- 600 planned
- Conditions
- Obesity; Metabolic Dysfunction-associated Steatotic Liver Disease
- Interventions
- Survodutide; Placebo matching survodutide
- Ages
- adults, older adults
- Registry
- NCT07850063, CTIS2026-527091-88-00
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
History
Primary completion expected
Expected to start
Last registry update
Registered