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.
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.
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.
Parallel
Survodutide
Combination productSurvodutide
Placebo matching survodutide
Combination productPlacebo matching survodutide
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
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)
Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated, disease-specific participant-reported outcome measure designed to assess heart failure-related health status. The study will administer the KCCQ 23-item version. All scores range from 0 to 100, with higher scores indicating fewer symptoms and better health status.
New use of oral loop diuretics during follow-up from baseline to 76 weeks, irrespective of symptoms (yes/no)
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This trial is not recruiting at the moment. You can still explore other options:
