Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Summary

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Timeline

Start

2021-04-01

Primary completion

2029-04-25

Completion

2029-04-25

Publications

• Results Newsome PN, Sanyal AJ, Engebretsen KA, Kliers I, Ostergaard L, Vanni D, Bugianesi E, Rinella ME, Roden M, Ratziu V. Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial. Aliment Pharmacol Ther. 2024 Dec;60(11-12):1525-1533. doi: 10.1111/apt.18331. Epub 2024 Oct 16.
• Sanyal AJ, Newsome PN, Kliers I, Ostergaard LH, Long MT, Kjaer MS, Cali AMG, Bugianesi E, Rinella ME, Roden M, Ratziu V; ESSENCE Study Group. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. N Engl J Med. 2025 Jun 5;392(21):2089-2099. doi: 10.1056/NEJMoa2413258. Epub 2025 Apr 30.
• Jensen EL, Israelsen M, Krag A. Transforming steatotic liver disease management: The emerging role of GLP-1 receptor agonists. Hepatol Commun. 2024 Oct 10;8(11):e0561. doi: 10.1097/HC9.0000000000000561. eCollection 2024 Nov 1.
• Rowe IA, Allen AM. Hepatic steatosis provides the terroir that promotes the development of cardiovascular risk factors and disease. Hepatology. 2023 Jun 1;77(6):1843-1845. doi: 10.1097/HEP.0000000000000327. Epub 2023 Feb 6. No abstract available.

Drugs

Indications