A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis
University Hospitals Birmingham NHS Foundation Trust · Inserm · +10 more institutions
Abstract
Nonalcoholic steatohepatitis (NASH) is a common disease that is associated with increased morbidity and mortality, but treatment options are limited. The efficacy and safety of the glucagon-like peptide-1 receptor agonist semaglutide in patients with NASH is not known.
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3. Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo. The primary end point was resolution of NASH with no worsening of fibrosis. The confirmatory secondary end point was an improvement of at least one fibrosis stage with no worsening of NASH. The analyses of these end points were performed only in patients with stage F2 or F3 fibrosis; other analyses were performed in all the patients.
Citation impact
- FWCI
- 120.95
- Percentile
- 100%
- References
- 28
Authors
9- PNPhilip N. NewsomeCorresponding
University Hospitals Birmingham NHS Foundation Trust, Inserm, Sorbonne Université, Centre de Recherche des Cordeliers, NIHR Birmingham Biomedical Research Centre
- KBKristine Buchholtz
University Hospitals Birmingham NHS Foundation Trust, Inserm, Novo Nordisk (Denmark), Sorbonne Université, Centre de Recherche des Cordeliers, NIHR Birmingham Biomedical Research Centre
- KCKenneth Cusi
University Hospitals Birmingham NHS Foundation Trust, Inserm, University of Florida, Sorbonne Université, Centre de Recherche des Cordeliers, NIHR Birmingham Biomedical Research Centre
- MLMartin Linder
University Hospitals Birmingham NHS Foundation Trust, Inserm, Novo Nordisk (Denmark), Sorbonne Université, Centre de Recherche des Cordeliers, NIHR Birmingham Biomedical Research Centre
- TOTakeshi Okanoue
University Hospitals Birmingham NHS Foundation Trust, Inserm, Sorbonne Université, Kyoto Prefectural University of Medicine, Centre de Recherche des Cordeliers, NIHR Birmingham Biomedical Research Centre
Topics & keywords
- Semaglutide
- Nonalcoholic steatohepatitis
- Medicine
- Placebo
- Internal medicine
- Steatohepatitis
- Gastroenterology
- Diabetes mellitus
- Good health and well-being