NCT03987451

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

Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks
DRUG	Placebo (semaglutide)	Semaglutide placebo s.c. given once-weekly for 48 weeks

Timeline

• Start date: 2019-06-18
• Primary completion: 2021-04-22
• Completion: 2021-06-10
• First posted: 2019-06-17
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

38 sites across 5 countries: United States, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study