A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

What this study is testing ClinicalTrials.gov NCT03987451 ↗

Description as written by the study sponsor.

Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Treatments tested

• Semaglutide Drug

  Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks

• Placebo (semaglutide) Drug

  Semaglutide placebo s.c. given once-weekly for 48 weeks