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About
This study is open to adults who are at least 18 years old and have
People with a history of other chronic liver diseases cannot take part in this study.
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
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Inclusion and exclusion criteria
Key inclusion criteria:
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
BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening:
History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.
Key exclusion criteria:
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups, including a placebo group
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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